National Medical Policy

Subject:

Endothelial Keratoplasty

Policy Number:

NMP534

Effective Date*: June 2014

Updated:

June 2015
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document

For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for
coverage guidelines prior to applying Health Net Medical Policies
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use

Source

National Coverage Determination

(NCD)
National Coverage Manual Citation
Local Coverage Determination (LCD)*
Article (Local)*
Other

Reference/Website Link

Noridian Medicare Part B. Descemets Stripping

with Automated Endothelial Keratoplasty
(DSAEK) Coding Change:
https://www.noridianmedicare.com/cgibin/coranto/viewnews.cgi?id=EkFppypZAuUJrcas
Wv&tmpl=part_b_viewnews&style=part_ab_vie
wnews
Coding and Reimbursements
http://www.ziemergroup.ch/fileadmin/media/pr
oducts/AMADEUS/Lamellar_Keratoplasty/Insight
s_on_Coding_DSEK.pdf
Palmetto GBA. Jurisdiction 11 Part B. Endothelial
Keratoplasty. Updated 2/27/2014:
http://www.palmettogba.com/palmetto/provider
s.nsf/DocsCat/Jurisdiction-11-PartB~8EELJH6113

None

Use Health Net Policy

Instructions
Endothelial Keratoplasty Jun 15

Medicare NCDs and National Coverage Manuals apply to ALL Medicare members
in ALL regions.
Medicare LCDs and Articles apply to members in specific regions. To access your
specific region, select the link provided under Reference/Website and follow the
search instructions. Enter the topic and your specific state to find the coverage
determinations for your region. *Note: Health Net must follow local coverage
determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their
service area when those MACs have exclusive coverage of an item or service. (CMS
Manual Chapter 4 Section 90.2)

If more than one source is checked, you need to access all sources as, on
occasion; an LCD or article contains additional coverage information than
contained in the NCD or National Coverage Manual.
If there is no NCD, National Coverage Manual or region specific LCD/Article,
follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement

Please see Health Net National Medical Policy on Refractive Surgery (LASIK, LASEK,
PRK, PARK and PRK-A)
Health Net, Inc. considers endothelial keratoplasty* using Descemets stripping
endothelial keratoplasty (DSEK), Descemets stripping automated endothelial
keratoplasty (DSAEK), Descemets membrane endothelial keratoplasty (DMEK), or
Descemets membrane automated endothelial keratoplasty (DMAEK) medically
necessary for the treatment of endothelial dysfunction, in individuals with endothelial
failure and otherwise healthy corneas, including but not limited to any of the
following:
1.
2.
3.
4.
5.
6.

Ruptures in Descemets membrane; or

Fuchs endothelial corneal dystrophy; or
Aphakic and pseudophakic bullous keratopathy; or
Iridocorneal endothelial (ICE) syndrome; or
Corneal edema attributed to endothelial failure; or
Failure or rejection of a previous corneal transplant.

*NOTE: Endothelial keratoplasty should not be used in place of penetrating

keratoplasty (PK) for conditions with concurrent endothelial disease and anterior
corneal dystrophies. These situations would include anterior corneal scars from
trauma or prior infection, and ectasia after previous laser vision correction surgery.
(AAO recommendation)
Health Net, Inc. considers femtosecond laser-assisted corneal endothelial
keratoplasty (FLEK) or femtosecond and excimer laser-assisted endothelial
keratoplasty (FELEK) investigational, since although there have been studies,
additional, larger, peer-reviewed studies are necessary to demonstrate the efficacy
and long-term outcomes of these procedures.

Endothelial Keratoplasty Jun 15

Key Words
Definitions
ALK
BSCVA
BK
DALK
DLEF
DLEK
DLKP
DMAEK
DMEK
DSAK
DSAEK
EBAA
EK
FECD
FELK
FELEK
PK
PTK

Anterior lamellar keratoplasty

Best spectacle corrected visual acuity
Bulbous keratopathy
Deep anterior lamellar keratoplasty
Deep lamellar endothelial keratoplasty
Deep lamellar endothelial keratoplasty
Deep lamellar keratoplasty
Descemet's membrane automated endothelial keratoplasty
Descemet's membrane endothelial keratoplasty
Descemet's stripping automated keratoplasty
Descemet's stripping automated endothelial keratoplasty
Eye Bank Association of America
Endothelial Keratoplasty
Fuchs endothelial corneal dystrophy
Femtosecond laser-assisted corneal endothelial keratoplasty
Femtosecond and excimer laser-assisted endothelial keratoplasty
Penetrating keratoplasty
Phototherapeutic keratectomy

Codes Related To This Policy

NOTE:
The codes listed in this policy are for reference purposes only. Listing of a code in
this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and
medical necessity criteria. This list of codes may not be all inclusive.
On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and
inpatient procedures will be replaced by ICD-10 code sets. Health Net National
Medical Policies will now include the preliminary ICD-10 codes in preparation for this
transition. Please note that these may not be the final versions of the codes and
that will not be accepted for billing or payment purposes until the October 1, 2015
implementation date.

ICD-9 Codes
371.20

Corneal edema, unspecified

371.21
371.22
371.23
371.24
371.33
371.57
371.58
996.51
996.53

Idiopathic corneal edema

Secondary corneal edema
Bullous keratopathy
Corneal edema due to wearing of contact lenses
Rupture in Descemet's membrane
Endothelial corneal dystrophy (Fuchs' endothelial dystrophy)
Other posterior corneal dystrophies
Mechanical complication due to corneal graft
Mechanical complication due to ocular lens prosthesis

ICD-10 Codes
H18.10H18.13
H18.20H18.239
H18.331H18.339

Bullous keratopathy
Other and unspecified corneal edema
Rupture in Descemet's membrane

Endothelial Keratoplasty Jun 15

H18.51
H18.59
08R83KZ
08R93KZ
T85.29XAT85.29XS
T86.840
T86.841
T86.848

Endothelial corneal dystrophy (Fuchs' endothelial dystrophy)

Other hereditary corneal dystrophies
Replacement of right cornea with nonautologous tissue substitute,
percutaneous approach
Replacement of left cornea with nonautologous tissue substitute,
percutaneous approach
Other mechanical complication of intraocular lens
Corneal transplant rejection
Corneal transplant failure
Other complications of corneal transplant

CPT Codes
65756
65757

Keratoplasty (corneal transplant); endothelial

Backbench preparation of corneal endothelial allograft prior to
transplantation

HCPCS Codes
N/A

Scientific Rationale Update June 2015

Kasbekar et al. (2014) completed a multicenter cohort study, to investigate graft
survival and surgical experience on clinical outcome following deep anterior lamellar
keratoplasty (DALK). The United Kingdom Transplant Database was used to identify
patients who had undergone a first DALK or penetrating keratoplasty (PKP) for
keratoconus. Data were collected at the time of surgery and at 1, 2, and 5 years
postoperatively. Graft survival, best-corrected visual acuity, and refractive error
were analyzed for 3 consecutive time periods. DALK outcomes were analyzed
according to surgeon experience. A total of 4521 patients were included. Graft
survival was 92% (95% CI: 90-92) for PKP and 90% (95% CI: 88-92) for DALK (P =
.09). For corneal transplants undertaken in the periods 1999-2002, 2002-2005, and
2005-2007, graft survival was 90%, 92%, and 88% following DALK, and 93%, 91%,
and 92% following PKP, respectively. There was no evidence of a difference between
surgeons in terms of case mix (P = .4) or outcome (P = .2). Surgeon experience, in
terms of the number of previous DALK undertaken, had no significant effect on
outcome. A donor recipient trephine size disparity of 0.5 mm was associated with an
increased risk of graft failure for both DALK (P = .03) and PKP (P = .002), whereas
ocular surface disease was a significant risk factor for DALK (P = .04) but not PKP.
Therefore, there has been little change in graft survival for DALK and PKP over the
past decade. Ocular surface disease is an important risk factor for graft failure
following DALK. A surgical learning curve for DALK could not be demonstrated in
terms of clinical outcome.
Keane et al. (2014) identified two completed studies, with a total of 111 participants
(n = 30 and n = 81), that met the authors inclusion criteria. Participants had
moderate to severe keratoconus pre-operatively and were randomly allocated to
receive either DALK or penetrating keratoplasty. Only one eye of each participant
was treated as part of the trials. The smaller study had 12 month follow-up data for
all participants. For the larger study, four DALK surgeries had to be abandoned due
to technical failure and visual and refractive outcomes were not measured in these
participants. Follow-up length for the remaining 77 participants ranged from 6.8 to
36.4 months, with all 77 followed for at least three months post-suture removal.
Details of the randomisation procedure were unavailable for the smaller study and so
sensitivity analyses were conducted to determine if the results from this study had
affected the overall results of the review. Neither of the included studies reported a
Endothelial Keratoplasty Jun 15

difference between groups on any of the measures of post-graft visual achievement,

keratometric astigmatism or spherical equivalent. A single case of graft failure in a
penetrating keratoplasty was reported. No postoperative graft failures were reported
in the DALK group of either study. Instances of graft rejection were reported in both
groups, in both studies. The majority of these cases were successfully treated with
steroids. The data, which related to all cases in each study - given that the four
cases that did not go ahead as planned had already technically failed without
presence of rejection - showed that rejection was less likely to occur in DALK (odds
ratio (OR): 0.33, 95% confidence interval (CI) 0.14 to 0.81, GRADE rating:
moderate). Results of the sensitivity analysis indicated that inclusion of the Razmju
2011 study did not bias the results with regards to rejection episodes. While
sensitivity analysis showed altered results with regards to failure rates, the data
available from the Javadi 2010 study alone had a very wide 95% CI, suggesting an
imprecise estimate. Therefore, even after removal of the Razmju 2011 data, it is still
difficult to draw conclusions regarding superiority of one technique over another with
regards to graft failure.DALK was unable to be completed as planned in four cases
and in a further three cases, complications during dissection required further
intervention. In recipients of DALK, one participant had interface neovascularisation
(a proliferation of blood vessels where the host and donor cornea come together)
and one had wrinkling of Descemet's membrane, the basement membrane
separating the corneal stroma from the corneal endothelium. In the penetrating
keratoplasty groups, one participant required graft resuturing and one had an atonic
pupil, a condition in which the pupil dilates and is non-reactive.Overall, the quality of
the evidence was rated as very low to moderate, with methodological limitations,
incomplete data analysis and imprecision of findings, as well as high risk of bias in
several areas for both studies. The authors found no evidence to support a difference
in outcomes with regards to BCVA at three months post-graft or at any of the other
time points analysed (GRADE rating: very low). The authors also found no evidence
of a difference in outcomes with regards to graft survival, final UCVA or keratometric
outcomes. Some evidence that rejection is more likely to occur following penetrating
keratoplasty than DALK (GRADE rating: moderate), was noted. The small number of
studies included in the review and methodological issues relating to the two, mean
that the overall quality of the evidence in this review is low. There is currently
insufficient evidence to determine which technique may offer better overall
outcomes, final visual acuity and time to attain this, keratometric stabilisation, risk of
rejection or failure, or both, and risk of other adverse events, for patients with
keratoconus. Large randomised trials comparing the outcomes of penetrating
keratoplasty and DALK in the treatment of keratoconus are needed. (Cochrane
Database Review 2014).

Scientific Rationale Initial

Penetrating keratoplasty (PK) was the primary corneal transplant technique and has
evolved over the years from the early 1900s, when this procedure was first
performed. At one time, conventional penetrating keratoplasty was the standard of
care. However, these techniques were accompanied by slower wound healing time
and decreased wound stability requiring tighter suture placement, which can lead to
decreased best spectacle corrected visual acuity (BSCVA) and significant
postoperative astigmatism.
Over the past 10 years, PK has been challenged by endothelial keratoplasty (EK) also
referred to as posterior lamellar keratoplasty, a procedure in which only the
abnormal part of the diseased cornea needs to be replaced, leaving the cornea
surface relatively untouched. Therefore, if the cornea has an endothelial problem,
then only the posterior cornea would need to be replaced. If it is a stromal problem,
the stroma is replaced and no surgery is necessary for the Descemet and
endothelium. This procedure is the preferred way to restore vision when the inner
Endothelial Keratoplasty Jun 15

cell layer of the cornea stops working properly, with bullous keratopathy, iridocorneal
endothelial (ICE) syndrome, or other endothelial disorders. Dr. Price, founder and
president of the Cornea Research Foundation, was an early pioneer of this procedure,
since 2002.
The endothelium or the diseased inner layer of the cornea is replaced with healthy
donor tissue, through a small incision, as part of the EK procedure. The healthy area
of the cornea is left intact. An air bubble is used to unfold and position the donor
tissue against the patients cornea. The small incision is either self-sealing or may
be closed with a few sutures. Specific techniques of endothelial keratoplasty include
Descemets stripping endothelial keratoplasty (DSEK), Descemets stripping
automated endothelial keratoplasty (DSAEK), Descemets membrane endothelial
keratoplasty (DMEK), or Descemets membrane automated endothelial keratoplasty
(DMAEK).
The most common types of EK procedures are DSEK and DSAEK, which are proposed
to leave the eye much stronger and less prone to injury than full-thickness
transplants. During DSEK hand-dissected donor tissue is used and diseased or
opacified corneal endothelial cells are stripped away. Grafts are applied to the
posterior 1/4 to 1/3 donor cornea thickness to the inner surface of the recipient
cornea. This technique is proposed to offer certain clinical advantages while
achieving the goal of penetrating keratoplasty in patients with disease largely related
to endothelial dysfunction. Patients without other eye problems usually achieve
average vision of 20/30 or better within a couple of months. This procedure is not
indicated for elective refractive surgery.
The donor corneal tissue and an artificial chamber on the individuals eye are
prepared prior to the DSAEK procedure. The donor tissue is cut with a
microkeratome, with a small incision from the temporal side of the cornea in order to
provide the greatest manual access and visualization. Two clear corneal incisions are
also placed about 5 clock hours apart to be used as access points to the anterior
chamber during the operation. This incision is a depth of 300-350 microns. The cut
donor tissue is then punched with a trephine to 9 mm in size for the transplant. A
big-bubble technique is then used to detach the central 6.0 to 7.0 mm of Descemet
membrane. The scleral rim is again mounted on an artificial anterior chamber. This
leaves a bare central Descemet membrane with an attached peripheral rim of
stroma. The graft is inserted and the graft's stromal rim allows it to spontaneously
unfold once inside the eye. The previously-prepared donor tissue is then folded with
a pair of special folding forceps and implanted into the anterior chamber of the eye.
After manipulations to center the donor tissue inside the eye and to remove the fluid
between the donor tissue and the host, the anterior chamber is then completely filled
with air to help with the adherence of the donor tissue to the endothelial side of the
cornea.
During the DMEK procedure, the endothelium and attached Descemets membrane
has to be peeled off the back of the donor cornea. The ultra-thin DMEK grafts are so
fragile that sometimes the precious donor tissue tears while separating the layers
and it cannot be salvaged. The preparation of the donor tissue is usually the biggest
issue with this procedure. Descemets membrane is only about 15 microns thick, so
the preparation has to be done very carefully. Once a DMEK graft is placed into the
patients eye, it usually curls up into a scroll. The scroll has to be unrolled and the
surgeon has to determine which side should face the recipient cornea and which side
should face the inside of the eye. Some techniques have been developed to help with
this, but it is still a complex surgery for the surgeon. The main advantage of DMEK
over DSEK/DSAEK is that the visual outcomes are better. After DMEK surgery about

Endothelial Keratoplasty Jun 15

75% of eyes may achieve a best corrected visual acuity of 20/25 or better within the
first 6 months after surgery. This difference may be explained by the near-anatomic
restoration with DMEK.
In DMAEK the donor graft just has the thin Descemets membrane and endothelium
in the center, with an outer rim of extra supporting tissue which is the thickness of a
DSEK / DSAEK graft. The outer ring of thicker tissue prevents the graft from curling
into a scroll and allows easier placement of the tissue in the patients eye. In the
DMAEK technique, the anterior stromal tissue is removed from the donor with a
Microkeratome, similar to what is done in DSAEK surgery. Next the donor tissue is
turned over and air is injected into the tissue to separate Descemets membrane
from the rest of the donor over the central 5 to 7 mm of the cornea. The
endothelium is then coated with a special viscoelastic material to protect it, remount
it on an artificial anterior chamber and remove the stromal tissue over the area
where the Descemets membrane was removed by the air. The DMAEK graft is now
ready to be cut with a round trephine to the sized needed for the patients eye, just
as is done for a standard penetrating keratoplasty or DSEK / DSAEK. More reinjections of air is done to keep the thin donor tissue up against the back of the
patients cornea during the first few days to weeks after surgery comparable to DSEK
/ DSAEK.
Fuchs endothelial corneal dystrophy (FECD) is an inherited autosomal dominant
degenerative progressive disease of the endothelial cells of the cornea, which has
been mapped to chromosome 13. There is often no known family history because
affected family members may have had mild or undiagnosed disease. It often results
in the development of corneal edema, and is estimated to have a prevalence of
approximately 4% in the United States. FECD is a leading cause for corneal
transplantation, with 13,107 of the 61,741 (21%) keratoplasties (penetrating or
endothelial) in 2012 performed for this condition according to the Eye Bank
Association of America. While clinical studies have led to a remarkable replacement
of penetrating keratoplasty by endothelial keratoplasty for the surgical management
of FECD over the last 5 years, efforts to determine the genetic risk factors underlying
FECD have been pursued concurrently. However, despite the prevalence of FECD,
only recently has research focused on examining disease characteristics and
comorbidities within the general population. Keratoplasty for FECD had been typically
reserved until a patient experienced a significant, persistent decrease in vision
throughout the day, not simply in the morning, when the cornea is most swollen.
Originally this was thought to occur when FECD reached a threshold where
compensatory mechanisms, such as the up-regulation of endothelial cell pumping
action with remaining normal endothelial cells, were insufficient to offset the
declining barrier function of the endothelium with FECD-affected diseased cells.
However, it was demonstrated from our cohort of cases and controls that an increase
in central corneal thickness occurs progressively with increasing severity of FECD,
including at stages of FECD where stromal and/or epithelial edema was not evident
on slitlamp examination (below grade 5). This suggests there may be clinical benefit
to measuring corneal thickness even at early stages of the disease to monitor
progression and subsequent timing of surgical intervention, particularly now that
endothelial keratoplasty is recommended at an earlier stage, before structural
damage to the stroma occurs from chronic edema. This approach may prove
particularly useful given the individual variation in baseline corneal thickness
in normal and FECD patients, even prior to any disease related changes. Tracking
changes in corneal thickness over time may better identify surgical candidates than
use of preoperative thresholds and could change standards of care.

Endothelial Keratoplasty Jun 15

Eyes with combined Fuchs dystrophy and keratoconus or a perforated herpes simplex
virus corneal ulcer or a central scar from a large full-thickness corneal laceration are
not great candidates for endothelial keratoplasty and are probably best served by a
PK. Some eyes with bullous keratopathy have significant anterior stromal haze from
the long-standing edema. While an EK and subsequent excimer laser
phototherapeutic keratectomy (PTK) or even a partial thickness anterior lamellar
keratoplasty could be performed after the EK healed, a single PK procedure is often
a better option.
Anterior lamellar keratoplasty was performed on a very limited basis until the
concept of baring the Descemet membrane and transplanting a full-thickness cornea,
minus the Descemet and endothelium, was developed. This deep anterior lamellar
keratoplasty (DALK) technique simplified the procedure in many ways and resulted in
better visual outcomes with much less interface haze. While the refractive and visual
results were typically no better than PK, the procedure had some advantages. The
primary advantage was no endothelial rejection, allowing for less postoperative
steroid use and potentially a longer lifespan of the graft. The primary reasons
DALK hasnt caught on are that it is much more time consuming than performing a
PK, involves numerous technical and visual outcome issues, and high rate of
intraoperative perforation of the Descemet membrane, often leading to conversion to
PK. The fact that it has a long learning curve, didnt help. Therefore, anterior lamellar
keratoplasties make up only a small percentage of the grafts performed in the United
States at this time. In cases of anterior corneal disease such as a central corneal
opacity, keratoconus, or anterior pigmentation of cornea, a penetrating keratoplasty
may be preferred.
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) and femtosecond
and excimer lasers-assisted endothelial keratoplasty (FELEK), are procedures that
were introduced in 2006 and utilize a laser. The femtosecond laser is an infrared
laser that delivers very short pulses of energy, on the order of femtoseconds or 1015 seconds, to make corneal cuts. With the use of software, the laser is preprogrammed to make cuts at specific depths, thereby creating the desired corneal
shape. These procedures include some donor stroma along with the endothelium and
Descemets membrane, which results in a thickened stromal layer after
transplantation. These techniques are a modification of traditional full-thickness
penetrating keratoplasty. FLEK and FELEK have not been shown to have improved
outcomes compared to existing techniques in peer reviewed studies.
Position Statements
The American Academy of Ophthalmology (Lee et al., 2009) notes that endothelial
keratoplasty procedures offer an alternative to penetrating keratoplasty to replace
diseased endothelium with healthy donor tissue, without the need to remove the
entire cornea. Descemet's stripping endothelial keratoplasty (DSEK) was introduced
in 2005, and Descemet's stripping automated endothelial keratoplasty (DSAEK) was
introduced in 2006. These procedures have replaced deep lamellar endothelial
keratoplasty (DLEK). These methods for endothelial keratoplasty (EK) involve
removal of Descemet's membrane and endothelium and replacement with donor
tissue. When donor tissue is comprised of Descemet's membrane and endothelium
alone, the technique is known as Descemet's membrane endothelial keratoplasty
(DMEK). The AAO position paper states that endothelial keratoplasty procedures are
associated with a smaller incision and faster visual rehabilitation than penetrating
keratoplasty. The AAO paper states that there remain concerns about potential
complications and long-term efficacy of endothelial keratoplasty, including concerns
about graft dislocations, endothelial cell loss, and failed grafts. The AAO position
paper cites the conclusions of an AAO Technology Assessment, which acknowledge
the relatively short-term follow up and varying surgical techniques in the literature,
Endothelial Keratoplasty Jun 15

but states "there is no evidence that DSAEK carries unacceptable risks for surgical
treatment of endothelial corneal disease. In comparison to PK, DSAEK appears at
least equivalent in terms of safety, efficacy, surgical risks, and complications rates
and superior to PK in terms of refractive stability, postoperative refractive outcomes,
wound and suture-related complications, and intraoperative choroidal hemorrhage
risk".
The AAO position paper was based in large part on a comprehensive review of the
literature on Descemets stripping automated endothelial keratoplasty (DSAEK) by
the American Academy of Ophthalmologys Ophthalmic Technology Assessment
Committee. The Technology Assessment Committee concluded that the evidence
reviewed suggests DSAEK appears safe and efficacious for the treatment of
endothelial diseases of the cornea. Evidence from retrospective and prospective
DSAEK reports described a variety of complications from the procedure, but these
complications do not appear to be permanently sight threatening or detrimental to
the ultimate vision recovery in the majority of cases. Long-term data on endothelial
cell survival and the risk of late endothelial rejection cannot be determined with this
review. DSAEK should not be used in lieu of PK for conditions with concurrent
endothelial disease and anterior corneal disease. These situations would include
concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior
infection, and ectasia after previous laser vision correction surgery.
The National Institute for Health and Clinical Excellence (NICE, 2008) found
adequate evidence to support the use of this procedure. The NICE assessment cited
comparative studies which found better visual acuity and a lower incidence of
astigmatism with endothelial keratoplasty compared with penetrating keratoplasty.
The specialist advisors to NICE listed adverse events of endothelial keratoplasty
reported in the literature or anecdotally as graft dislocation, graft failure and
rejection, interface opacification, and loss of best spectacle corrected visual acuity.
Eye Bank Association of America (EBAA) statistics show the number of EK cases in
the United States increased from 1,429 in 2005 to 23,409 in 2012. The EBAA report
estimates that approximately 1/2 of corneal transplants performed in the U.S. were
endothelial grafts. As with any new surgical technique, questions have been posed
about long-term efficacy and the risk of complications. EK-specific complications
include graft dislocations, endothelial cell loss, and rate of failed grafts. Long-term
complications include increased intraocular pressure, graft rejection, and late
endothelial failure. Also of interest is the impact of the surgeons learning curve on
the risk of complications.
Studies
Price et al. (2010) completed a multicenter, prospective, nonrandomized clinical trial,
the Cornea Donor Study which compared Descemet's stripping endothelial
keratoplasty (DSEK) with penetrating keratoplasty (PKP). Two surgeons performed
DSEK on 173 patients, with the following findings at 3 years:
111 patients (64%) were examined and found to have clear grafts;
44 patients (25%) had clear grafts when last examined but withdrew or were lost
to follow-up before the 3-year evaluation;
11 patients (6.4%) had died; and
7 patients (4%) had graft failure.

Endothelial Keratoplasty Jun 15

The investigators calculated a cumulative probability of a DSEK graft survival of 94%

at 3 years. The 3-year graft survival rate was 96% for both the DSEK and PKP eyes
with Fuchs dystrophy, and 86% for the DSEK eyes verses 84% for the PKP eyes with
other preoperative diagnoses. Statistically significantly fewer immunologic graft
rejection episodes occurred in the DSEK group (6.4%) vs the PKP group (20%) at 3
years (P = .0005). At 3 years, the median endothelial cell loss was similar for the
DSEK and PKP groups (48% vs 53%, respectively, P = .17). Eyes with Fuchs
dystrophy had less endothelial cell loss than eyes with other preoperative diagnoses,
but it was similar for the DSEK and PKP eyes. Of interest, DSEK eyes had more
endothelial cell loss than the PKP eyes at 1 year but less cell loss over the
subsequent 2 years. The 2 sites in this study used different incision lengths: 3.2 mm
and 5.0 mm. The significantly greater cell loss observed in the 3.2-mm-incision eyes
compared with the 5.0-mm-incision eyes at 1 year persisted at 3 years (60% vs
33%, P = .0007). The 5.0-mm incision showed significantly less cell loss in the DSEK
eyes than in the PKP eyes at 3 years (33% vs 53%, P = .0017). Compared with PK,
DSAEK resulted in lower EC loss with comparable cumulative graft survival rates for
up to 3 years in patients with Fuchs' dystrophy and bulbous keratopathy (BK).
Straiko et al. (2011) completed a retrospective analysis of a prospectively collected
dataset. All 17 eyes with a preoperative diagnosis of failed penetrating keratoplasty
graft were identified out of a total pool of 793 eyes that had received DSAEK for
endothelial dysfunction in a prospective Institutional Review Boardapproved study
of endothelial keratoplasty. A standard surgical strategy of careful slit-lamp
examination and preoperative optical coherence tomography (OCT) to determine
optimal DSAEK graft diameter was combined with undersized Descemet stripping and
peripheral bed scraping. A total of 17 eyes in 16 patients were identified. The DSAEK
graft size ranged from 7.0 to 8.0 mm, with all DSAEK graft diameters less than or
equal to the PK diameter. The average follow-up was 16 months (range 2-38
months). All PK grafts cleared and the visual acuity improved in all patients. There
were no cases of pupillary block or primary graft failure. There was 1 dislocation
(5.9%). The dislocation occurred in an eye with aniridia, prior trabeculectomy, and
scleromalacia with postoperative hypotony from a wound leak. DSAEK for failed PK
using DSAEK grafts with a diameter less than or equal to the PK diameter allowed
improved vision with a low complication rate. Preoperative OCT of posterior PK
contour can aid in graft diameter selection.
Nanavaty et al. (2014, Cochrane Database) Two authors independently screened the
search results, that included 3 RCTs comparing EK versus PKP for people, of any age
and gender, who had been clinically diagnosed with Fuchs endothelial dystrophy
(FED). This included a total of 139 eyes of 136 participants and analyzed 123 (88%)
eyes. Two RCTs randomised eyes into either the endothelial keratoplasty (EK) group
or penetrating keratoplasty (PKP) group and one RCT randomised eyes into either
the femtosecond laser-assisted endothelial keratoplasty (FLEK) group or PKP group.
The RCTs comparing EK with PKP did not show any significant differences between
procedures with respect to best corrected visual acuity (BCVA) at two years (mean
difference (MD) 0.14 logMAR; 95% confidence interval (CI) -0.08 to 0.36; P = 0.23)
or at one year (MD 0.09 logMAR; 95% CI -0.05 to 0.23; P = 0.22), whereas the trial
comparing FLEK with PKP showed significantly better BCVA after PKP (MD 0.20
logMAR; 95% CI 0.10 to 0.30; P = 0.0001). Only one RCT reported on irregular
astigmatism (higher-order aberration), which was less with EK than PKP (MD -1.20
m; 95% CI -1.53 to -0.87; P < 0.001). Only one RCT reported on endothelial cell
counts (lower after FLEK than PKP: MD -969 cells/mm; 95% CI -1161 to -777; P <
0.001), primary graft failure (higher after FLEK than PKP: RR 7.76; 95% CI 0.41 to
145.22; P = 0.10), and graft rejection (more after FLEK than PKP: RR 1.11; 95% CI
0.07 to 17.12; P = 0.94). Only one RCT reported that 27.8% of participants had
graft dislocation, 2.8% had epithelial ingrowth and postoperative pupillary block, and
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13.9% had intraocular pressure (IOP)-related problems in the FLEK group compared
with the PKP group, in whom 10% had suture-related problems, 5% had wound
dehiscence and 10% had suture revision to correct astigmatism. Overall, the adverse
events in the FLEK group appeared to be more frequent than in the PKP group. No
trials reported information about quality of life or economic data. The overall
methodological quality of the three trials was not satisfactory as most did not
perform allocation concealment or masking of participants and outcome assessors,
and all trials had a small sample size. The rapid growth of endothelial keratoplasty as
the treatment of choice for FED is based upon the belief that visual recovery is more
rapid, surgically induced astigmatism, regular and irregular, is less and rates of
transplant rejection are lower with EK. This change in practice also assumes that the
rates of long term transplant survival are equal for the two procedures. The practical
differences between the surgical procedures mean that visual recovery is inherently
more rapid following EK, but this review found no strong evidence from RCTs of any
difference in the final visual outcome between EK and PKP for people with FED. This
review also found that higher order aberrations are fewer following EK but
endothelial cell loss is greater following EK. The RCTs that we included employed
different EK techniques, which may have a bearing on these findings. EK procedures
have evolved over the years and can be performed using different techniques, for
example deep lamellar endothelial keratoplasty, Descemets stripping endothelial
keratoplasty (DSEK), Descemets stripping automated endothelial keratoplasty
(DSAEK), femtosecond laser-assisted endothelial keratoplasty and Descemet
membrane endothelial keratoplasty (DMEK). More RCTs are needed to compare PKP
with commonly performed EK procedures such as DSEK, DSAEK and DMEK in order
to determine the answers to two key questions, whether there is any difference in
the final visual outcome between these techniques and whether there are differences
in the rates of graft survival in the long term.
There are a number of ongoing Clinical Trials. There is one that is currently recruiting
participants Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK)
and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
The ClinicalTrials.gov Identifier is NCT02020044, and it was last verified in December
2013. The purpose of this study is to evaluate the outcome after posterior lamellar
keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation. The estimated
primary completion date is December 2015.
Another Clinical trial on Study of Endothelial Keratoplasty Outcomes, also currently
recruiting participants. The ClinicalTrials.gov Identifier is NCT00800111, and it was
last updated November 2013. Endothelial keratoplasty is undergoing rapid and
widespread adoption. Between 2005 and 2007, the number of corneas placed by US
eye banks for endothelial keratoplasty increased ten-fold (i.e., 2007 Eye Bank
Association of America Annual Report). However, the procedure is less than 10 years
old, and little is known about long term outcomes. Endothelial keratoplasty
candidates at our center are invited to participate in an open enrollment, prospective
study of the long-term outcomes of this procedure. The estimated primary
completion date is February 2018.
Chamberlain et al. (2013) completed a non-randomized retrospective comparative
study involving 100 subjects, in which FLEK (n=50) was compared to PK (n=50).
Significantly lower topographic astigmatism was achieved in the FLEK group over the
PK group in the 4 to 6 month follow-up period (p=0.0324). However, this difference
was not present in any other follow-up period up to 24 months postoperatively. A
subset analysis of subjects with keratoconus or post-LASIK ectasia did not show any
difference in either astigmatism or visual acuity at any time. No significant
improvement in BSCVA was noted at any time point.

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Vetter et al. (2013) completed a small (n=22) retrospective cohort study and
reported a reduction in visual acuity when the endothelial transplant was prepared
with FLEK vs. DSAEK. There was also greater surface irregularity with the laserassisted EK. Given this data, it is unclear that there is any benefit to FLEK, and it
may be deduced by the available evidence that PK may be superior to FLEK with
regard to postoperative visual acuity.
Cheng et al. (2011) reported a prospective, randomized clinical trial involving 80
subjects (80 eyes) with corneal endothelial dysfunction randomized to undergo FLEK
or PK. At the end of 12 months, only 29 (72.5%) FLEK subjects were available for
analysis vs. 39 (97.5%) in the PK group. In the FLEK group, postoperative refractive
and topographic astigmatism values were not significantly different from
preoperative values. In the PK group, all postoperative refractive and topographic
astigmatism values were significantly higher compared with those before surgery. At
twelve months after surgery, the percentage of subjects with a refractive
astigmatism of 3.0 D was significantly higher in the FLEK group compared with the
PK group (86.2% vs. 51.3%, p=0 .004). Post-operatively, the mean BSCVA in the PK
group was significantly better when compared with the FLEK group at all follow-up
visits. The mean gain in BSCVA at 12 months was not significantly different between
the FLEK and PK groups (p=0.103).
Cheng et al. (2009) completed a randomized trial comparing FLEK with PK for 80
subjects (80 eyes) with Fuchs' endothelial dystrophy, pseudophakic bullous
keratopathy, or posterior polymorphous dystrophy, and best spectacle-corrected
visual acuity less than 20/50. Subjects were randomly assigned in a 1:1 manner. In
the FLEK group, 4 of the 40 eyes which did not receive the procedure were excluded
from the analysis. Eight eyes failed (22% of 36), and 2 participants were lost to
follow-up due to death. In the PK group only 1 participant was lost to follow-up. At
12 months postoperatively, refractive astigmatism was lower in the FLEK group than
the PK group (86% vs. 51%), but there was greater hyperopic shift. Mean BCVA was
better following PK than FLEK at 3-, 6-, and 12-month follow-up. Endothelial cell loss
was reported as greater in the FLEK group (65%) vs. the PK group (23%). With the
exception of dislocation and need for repositioning of the FLEK grafts in 28% of eyes,
the percentage of complications were similar in the 2 groups. Complications in the
FLEK group were due to pupillary block, graft failure, epithelial ingrowth, and
elevated intraocular pressure, whereas complications in the PK group were related to
the sutures and elevated intraocular pressure. The authors concluded that FLEK
effectively reduced postoperative astigmatism and eliminated wound healing related
problems compared to PK. However, they note that visual acuity is lower compared
with conventional PK, and the rate of endothelial cell loss warrants further
investigation.
In summary, although the majority of the studies on endothelial keratoplasty (EK)
are not RCTs, they seem to have promising results at this time. In addition, this
procedure is less invasive than penetrating keratoplasty since only the diseased part
of the cornea needs to be replaced. The studies indicate potential advantages of the
procedure in terms of more rapid recovery of visual acuity than penetrating
keratoplasty (PK) without causing significant refractive errors. ions. There are two
ongoing Clinical Trials to evaluate the outcomes of endothelial keratoplasty but they
will not be completed until 2015 and 2018.
Per the American Academy of Ophthalmology (2013) the ongoing development of
endothelial keratoplasty from DLEK to DSEK/DSAEK to DMEK/DMAEK, and possibly
DMET, indicates that there has a decreasing number of penetrating keratoplasties.
The number of EKs has now surpassed the number of PKs performed in the United
States. There are many reasons for this rapid conversion, including faster surgery,
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less change in corneal curvature, fewer suture-related complications, and a stronger

wound. Longer-term graft survival with these new techniques is presently unknown.
However, current procedures result in acceptable short-term survival, and additional
surgical intervention can be performed with a low risk of vision loss. Due to the
marked reduction in serious complications compared to the alternative, DSEK/DSAEK
has become the preferable approach for endothelial dysfunction among corneal
surgeons. DMEK/DMAEK have also become accepted approaches to EK, due to a
reduction in stromal haze and improvement in visual acuity.

Review History
June 2014
June 2015

Medical Advisory Council, initial approval

Update no revisions. Codes updated.

This policy is based on the following evidence-based guidelines:

1.
2.
3.
4.
5.

American Academy of Ophthalmology (AAO). Cornea 2013. Through the Looking

Glass Where We Are, Where Were Headed.
American Academy of Ophthalmology Health Policy Committee Position Paper on
Endothelial Keratoplasty, (2009 January 29).
Lee WB, Jacobs DS, Musch DC, et al. Descemet's stripping endothelial
keratoplasty: Safety and outcomes: A report by the American Academy of
Ophthalmology. Ophthalmology. 2009;116(9):1818-1830.
Hayes. Health Technology Brief. Descemet Stripping with Manual or Automated
Endothelial Keratoplasty for Corneal Endothelial Degeneration. March 2, 2011.
Archived March 9, 2012.
National Institute for Health and Clinical Excellence (NICE). Corneal endothelial
transplantation. December 2008. Updated June 2009. Available at:
http://www.nice.org.uk/nicemedia/pdf/IPG304Guidance.pdf

References Update June 2015

1. Coster DJ, Lowe MT, Keane MC, et al. A comparison of lamellar and penetrating
keratoplasty outcomes: a registry study. Ophthalmology. 2014; 121(5):979-987.
2. Fan Gaskin JC, Patel DV, McGhee CN. Acute corneal hydrops in keratoconus - new
perspectives. Am J Ophthalmol 2014; 157:921.
3. Kasbekar SA, Jones MN, Ahmad S, et al. Corneal transplant surgery for
keratoconus and the effect of surgeon experience on deep anterior lamellar
keratoplasty outcomes. Am J Ophthalmol 2014; 158:1239.
4. Keane M, Coster D, Ziaei M, et al. Deep anterior lamellar keratoplasty versus
penetrating keratoplasty for treating keratoconus. Cochrane Database Syst Rev
2014; 7:CD009700.
5. Lockington D, Fan Gaskin JC, McGhee CN, et al. A prospective study of acute
corneal hydrops by in vivo confocal microscopy in a New Zealand population with
keratoconus. Br J Ophthalmol 2014; 98:1296.
6. Mitry D, Bhogal M, Patel AK, et al. Descemet stripping automated endothelial
keratoplasty after failed penetrating keratoplasty: survival, rejection risk, and
visual outcome. JAMA Ophthalmol. 2014; 132(6):742-749.
7. Perez JF, Valero MA, Martnez PFJ. Early diagnosis of keratoconus: what
difference is it making? Br J Ophthalmol 2014; 98:1465.
8. Stem M, Webster LS, Mian SI, et al. Descemet Membrane Endothelial
Keratoplasty for Graft Failure After Descemet Stripping Endothelial Keratoplasty:
Clinical Results and Histopathologic . JAMA Ophthalmology.

References Initial
1.

Allan B, Terry MA, Price FW, et al. Corneal transplant rejection rate and severity
after endothelial keratoplasty. Cornea 2007; 26:1039-42.

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2.

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Chen ES, Terry MA, et al. Endothelial keratoplasty: vision, endothelial survival,
and complications in a comparative case series of fellows vs. attending surgeons.
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keratoplasty: six-month results in a prospective study of 100 eyes. Corneal.
2008; 27(5):514-520.
Cheng YY, van den Berg TJ, Schouten JS, et al. Quality of vision after
femtosecond laser-assisted descemet stripping endothelial keratoplasty and
penetrating keratoplasty: a randomized, multicenter clinical trial. Am J
Ophthalmol. 2011; 152(4):556-566.
Cheng YY, Schouten JS, et al. Efficacy and safety of femtosecond laser-assisted
corneal endothelial keratoplasty: a randomized multicenter clinical trial.
Transplantation (2009) 88(11):1294-302.
Chih A, Lugo M, Kowinqo D. Descemet stripping and automated endothelial
keratoplasty: an alternative to penetrating keratoplasty. Optom Vis Sci. 2008;
85(3):152-157.
Clinicaltrials.gov. Outcome After Descemet Membrane Endothelial Keratoplasty
(DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty
(DSAEK). ClinicalTrials.gov Identifier:NCT02020044. December 2013. Available
at:
http://www.clinicaltrials.gov/ct2/show/NCT02020044?term=endothelial+keratop
lasty&rank=1
Clinicaltrials.gov. Study of Endothelial Keratoplasty Outcomes. ClinicalTrials.gov
Identifier: NCT00800111. November 2013. Available at:
http://www.clinicaltrials.gov/ct2/show/NCT00800111?term=endothelial+keratop
lasty&rank=2
Clinicaltrials.gov. Descemet Stripping (Automated) Endothelial Keratoplasty
(DSEK or DSAEK). ClinicalTrials.gov Identifier: NCT00543660.
Covert DJ, Koenig SB. Descemet stripping and automated endothelial
keratoplasty (DSAEK) in eyes with failed penetrating keratoplasty. Cornea.
2007; 26(6):692-696.
Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEKthe thinner the better? Curr Opin Ophthalmol 2009; 20(4):299-307.
Den S, Shimmura S, et al. Impact of the Descemet membrane perforation on
surgical outcomes after deep lamellar keratoplasty. American Journal of
Ophthalmology (2007 May) 143(5):750-4.
Ehlers JP, Shah CP, eds. The Wills Eye Manual. 5th ed. Philadelphia: Lippincott
Williams & Wilkins; 2008. 94-95.
Feng MT, Price MO, Price FW Jr. Update on Descemet membrane endothelial
keratoplasty. Int Ophthalmol Clin. 2013; 53(2):31-45.
Fontana L, Parente G, et al. Clinical outcomes after deep anterior lamellar
keratoplasty using the big-bubble technique in patients with keratoconus.
American Journal of Ophthalmology (2007 January) 143(1):117-24.
Guerra FP, Anshu A, Price MO, et al. Descemet's membrane endothelial
keratoplasty: prospective study of 1-year visual outcomes, graft survival, and
endothelial cell loss. Ophthalmology. 2011; 118(12):2368-2373.
Ham L, Dapena I, van Luijk C, et al. Descemet membrane endothelial
keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50
consecutive cases. Eye. 2009 Jan 30. [Epub ahead of print]

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20. Ho C, Cunningham J. Descemet stripping automated endothelial keratoplasty: A

review of the clinical and cost-effectiveness. Ottawa, ON: Canadian Agency for
Drugs and Technologies in Health (CADTH). 2009.
21. Hyams M, Segev F, et al. Early postoperative complications of deep lamellar
endothelial keratoplasty. Cornea (2007 July) 26(6):650-3.
22. Jordan CS, Price MO, Trespalacios R, et al. Graft rejection episodes after
Descemet stripping with endothelial keratoplasty: part one: clinical signs and
symptoms. Br J Ophthalmol 2009;93:387-09.
23. Koenig SB, Covert DJ. Early results of small-incision Descemet's stripping and
automated endothelial keratoplasty. Ophthalmology. 2007;114(2):221-226.
24. Kosker M, Suri K, Duman F, et al. Long-term outcomes of penetrating
keratoplasty and Descemet stripping endothelial keratoplasty for Fuchs
endothelial dystrophy: fellow eye comparison. Cornea. Epub ahead of print 2013
Apr 30.
25. McCauley MB, Price FW Jr, Price MO. Descemet membrane automated
endothelial keratoplasty: hybrid technique combining DSAEK stability with DMEK
visual results. J Cataract Refract Surg. 2009 Oct;35(10):1659-64. doi:
10.1016/j.jcrs.2009.05.034.
26. McCauley, M.B., Price, M.O., et al. Prospective study of visual outcomes and
endothelial survival with Descemet membrane automated endothelial
keratoplasty. Cornea (2011) 30(3):315-9.
27. Mearza AA, Qureshi MA, Rostron CK. Experience and 12-month results of
descemet-stripping endothelial keratoplasty (DSEK) with a small-incision
technique. Cornea. 2007;26(3):279-283.
28. Nanavaty Mayank A, Shortt Alex J. Endothelial keratoplasty versus penetrating
keratoplasty for Fuchs endothelial dystrophy. Cochrane Database Syst Rev.
2011;(7):CD008420. Update in Cochrane Database Syst Rev.
2014;2:CD008420.
29. Noble BA, Agrawal A, et al. Deep Anterior Lamellar Keratoplasty (DALK): visual
outcome and complications for a heterogeneous group of corneal pathologies.
Cornea (2007 January) 26(1):59-64.
30. Oster SF, Ebrahimi KB, Eberhart CG, et al. A clinicopathologic series of primary
graft failure after Descemet's stripping and automated endothelial keratoplasty.
Ophthalmology. 2009116(4):609-614.
31. Price MO, Gorovoy M, Benetz BA, et al. Descemets stripping automated
endothelial keratoplasty 3-year graft and endothelial survival compared with
penetrating keratoplasty. Ophthalmology 2013; 120:246-251.
32. Price FW, Price, MO. Adult keratoplasty: has the prognosis improved in the last
25 years? Ophthalmology International, 2008; 28:141-146.
33. Price MO, Price FW. Endothelial cell loss after descemet stripping with endothelial
keratoplasty influencing factors and 2-year trend. Ophthalmology. 2008;
115:857-865.
34. Price FW Jr, Price MO. Descemet's stripping with endothelial keratoplasty in 200
eyes. J Cataract Refract Surg. 2006 32:411-8.
35. Price FW Jr, Price MO. Descemet's Stripping with Endothelial Keratoplasty
:Comparative Outcomes, in Ophthalmology, August 2006.
36. Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin
Ophthalmol. 2007;18(4):290-294.
37. Rose L, Kelliher C, Jun AS. Endothelial keratoplasty: historical perspectives,
current techniques, future directions. Can J Ophthalmol 2009; 44(4):401-5.
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preparations in Descemets membrane endothelial keratoplasty. Ophthalmology.
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dislocation after deep lamellar endothelial keratoplasty. American Journal of
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40. Straiko MD, Terry MA, Shamie N. Descemet Stripping Automated Endothelial
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Minimize Complications. American Journal of Ophthalmology - Volume 151, Issue
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automated endothelial keratoplasty: survey of 118 eyes at one institute.
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42. Terry MA, Chen ES, Shamie N, et al. Endothelial cell loss after Descemet's
stripping endothelial keratoplasty in a large prospective series. Ophthalmology.
2008; 115(3):488-496.
43. Terry MA, Ousley PJ. Deep Lamellar Endothelial Keratoplasty: Visual Acuity,
Astigmatism, and Endothelial Survival in a Large Prospective Series.
Ophthalmology. 2005. 112:1541-8.
44. Vajaranant TS, Price MO, Price FW, et al. Visual acuity and intraocular pressure
after Descemets stripping endothelial keratoplasty in eyes with and without
preexisting glaucoma. Ophthalmology 2009;116:1644-50.
45. van Dijk K, Ham L, Tse WH, et al. Near complete visual recovery and refractive
stability in modern corneal transplantation: Descemet membrane endothelial
keratoplasty (DMEK). Cont Lens Anterior Eye. 2013; 36(1):13-21.
46. Van Dooren BT, Mulder PG, et al. Endothelial cell density after posterior
lamellar keratoplasty: five-to seven-year follow-up. American Journal of
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eyes: a refractive neutral corneal transplant. J Refract Surg. 22:529-30.
48. Vetter JM, Butsch C, Faust M, et al. Irregularity of the posterior corneal surface
after curved interface femtosecond laser-assisted versus microkeratome-assisted
descemet stripping automated endothelial keratoplasty. Cornea. 2013;
32(2):118-124.
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keratoplasty: one-year results (2007 June) 26(5):530-3.
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