Coverage Policy Manual
Policy #: 2009024
Category: Surgery
Initiated: August 2009
Last Review: September 2018
  Endothelial Keratoplasty

Description:
Endothelial keratoplasty (EK), also referred to as posterior lamellar keratoplasty, is a form of corneal transplantation in which the diseased inner layer of the cornea, the endothelium, is replaced with healthy donor tissue. Specific techniques include Descemet’s stripping endothelial keratoplasty, Descemet’s stripping automated endothelial keratoplasty, or Descemet’s membrane endothelial keratoplasty.
 
The cornea, a clear, dome-shaped membrane that covers the front of the eye, is a key refractive element of the eye. Layers of the cornea consist of the epithelium (outermost layer); Bowman’s layer; the stroma, which comprises approximately 90% of the cornea; Descemet’s membrane; and the endothelium. The endothelium removes fluid from the stroma and limits its entry, thereby maintaining the ordered arrangement of collagen and preserving the cornea’s transparency. Diseases that affect the endothelial layer include Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy (corneal edema following cataract extraction), and failure or rejection of a previous corneal transplant.
 
The established surgical treatment for corneal disease is penetrating keratoplasty (PK), which involves the creation of a large central opening through the cornea and then filling the opening with full-thickness donor cornea that is sutured in place. Visual recovery after PK may take a year or more due to slow wound healing of the avascular full-thickness incision, and the procedure frequently results in irregular astigmatism due to the sutures and the full-thickness vertical corneal wound. PK is associated with an increased risk of wound dehiscence, endophthalmitis, and total visual loss after relatively minor trauma for years after the index procedure. There is also risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage, in which the ocular contents are expelled during the operative procedure, as well as postoperative catastrophic wound failure.
 
A number of related techniques have been, or are being, developed to selectively replace the diseased endothelial layer. One of the first endothelial keratoplasty (EK) techniques was termed deep lamellar endothelial keratoplasty (DLEK), which used a smaller incision than PK, allowed more rapid visual rehabilitation, and reduced postoperative irregular astigmatism and suture complications. Modified EK techniques include endothelial lamellar keratoplasty, endokeratoplasty, posterior corneal grafting, and microkeratome-assisted posterior keratoplasty. Most frequently used at this time are Descemet’s stripping endothelial keratoplasty (DSEK), which uses hand-dissected donor tissue, and Descemet’s stripping automated endothelial keratoplasty (DSAEK), which uses an automated microkeratome to assist in donor tissue dissection. A laser may also be utilized for stripping in a procedure called femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK). These techniques include some donor stroma along with the endothelium and Descemet’s membrane, which results in a thickened stromal layer after transplantation. If the donor tissue comprises Descemet’s membrane and endothelium alone, the technique is known as Descemet’s membrane endothelial keratoplasty (DMEK). By eliminating the stroma on the donor tissue and possibly reducing stromal interface haze, DMEK is considered to be a potential improvement over DSEK/DSAEK. A variation of DMEK is Descemet’s membrane automated EK (DMAEK). DMAEK contains a stromal rim of tissue at the periphery of the DMEK graft to improve adherence and increase ease of handling of the donor tissue.
 
EK involves removal of the diseased host endothelium and Descemet’s membrane with special instruments through a small peripheral incision. A donor tissue button is prepared from corneoscleral tissue after removing the anterior donor corneal stroma by hand (e.g., DSEK) or with the assistance of an automated microkeratome (e.g., DSAEK) or laser (FLEK or FELEK). Several microkeratomes have received clearance for marketing through the U.S. Food and Drug Administration (FDA) 510(k) process. Donor tissue preparation may be performed by the surgeon in the operating room, or by the eye bank and then transported to the operating room for final punch out of the donor tissue button. To minimize endothelial damage, the donor tissue must be carefully positioned in the anterior chamber. An air bubble is frequently used to center the donor tissue and facilitate adhesion between the stromal side of the donor lenticule and the host posterior corneal stroma. Repositioning of the donor tissue with application of another air bubble may be required in the first week if the donor tissue dislocates. The small corneal incision is closed with one or more sutures, and steroids or immunosuppressants may be provided either topically or orally to reduce the potential for graft rejection. Visual recovery following EK is typically achieved in 4-8 weeks, in comparison with the year or more that may be needed following PK.
 
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 surgeon’s learning curve on the risk of complications.
 
 

Policy/
Coverage:
EFFECTIVE SEPTEMEBER 2013
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Endothelial keratoplasty (Descemet’s stripping endothelial keratoplasty [DSEK], Descemet’s stripping automated endothelial keratoplasty [DSAEK], Descemet’s membrane endothelial keratoplasty [DMEK], or Descemet’s membrane automated endothelial keratoplasty [DMAEK])  meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of endothelial dysfunction, including but not limited to:
 
    • Ruptures in Descemet’s membrane,
    • Endothelial dystrophy,
    • Aphakic and pseudophakic bullous keratopathy,
    • Iridocorneal endothelial (ICE) syndrome,
    • Corneal edema attributed to endothelial failure, AND
    • Failure or rejection of a previous corneal transplant.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Endothelial keratoplasty does not meet member benefit Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for conditions with concurrent endothelial disease and anterior corneal disease.  This includes, but is not limited to: concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery.
 
For contracts without Primary Coverage Criteria, endothelial keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease, including but not limited to concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.  
 
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) or femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO SEPTEMEBER 2013
Endothelial keratoplasty (Descemet’s stripping endothelial keratoplasty or Descemet’s stripping automated endothelial keratoplasty) meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of endothelial dysfunction, including but not limited to Fuchs’ endothelial dystrophy, aphakic and pseudophakic bullous keratopathy, and failure or rejection of a previous corneal transplant.
 
Endothelial keratoplasty does not meet member benefit Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes for conditions with concurrent endothelial disease and anterior corneal disease.  This includes, but is not limited to: concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery.
 
For contracts without Primary Coverage Criteria, endothelial keratoplasty for conditions with concurrent endothelial disease and anterior corneal disease, including but not limited to concurrent anterior corneal dystrophies, anterior corneal scars from trauma or prior infection and ectasia after previous laser vision correction surgery is considered investigational.  Investigational services are exclusions in the member benefit certificate of coverage.  

Rationale:
Descemet’s Stripping Endothelial Keratoplasty and Descemet’s Stripping Automated Endothelial Keratoplasty (DSEK/DSAEK)
 
A 2009 review of the safety and efficacy of DSAEK, performed by the American Academy of Ophthalmology’s (AAO) Ophthalmic Technology Assessment Committee, identified 1 level I study (randomized controlled trial of precut vs. surgeon dissected) along with 9 level II (well-designed observational studies) and 21 level III studies (mostly retrospective case series).  Although more than 2,000 eyes treated with DSAEK were reported on in different publications, most were reported by one research group with some overlap in patients. The main results from this evidence review are as follows:
 
•DSAEK-induced hyperopia ranged from 0.9 to 1.5 diopters (D), with minimal induction of astigmatism (ranging from 0 to 0.6 D).
 
•The reporting of visual acuity was not standardized in the studies reviewed. The average best-corrected visual acuity (BCVA) ranged from 20/33 to 20/66, and the percentage of patients seeing 20/40 or better ranged from 38% to 100%.
 
•The most common complication from DSAEK in the studies reviewed was posterior graft dislocation (mean 14%; range 0–82%), with a lack of adherence of the donor posterior lenticule to the recipient stroma, typically occurring within the first week. It was noted that this figure may be skewed by multiple publications from one research group with low complication rates. Graft dislocation required additional surgical procedures (rebubble procedures) but did not lead to sight-threatening vision loss in the articles reviewed.
 
•Endothelial graft rejection occurred in an average 10% of patients (range, 0–45%); most were reversed with topical or oral immunosuppression, with some cases progressing to graft failure. Primary graft failure, defined as unhealthy tissue that has not cleared within 2 months, occurred in 5% of patients (range 0–29%). Iatrogenic glaucoma occurred in an average of 3% of patients (range 0–15%) due to a pupil block induced from the air bubble in the immediate postoperative period or delayed glaucoma from topical corticosteroid side effects.
 
•Endothelial cell loss, which provides an estimate of long-term graft survival, was an average 37% at 6 months and 42% at 12 months. This percentage of cell loss was reported to be similar to that observed with PK.
 
The technology assessment concluded that DSAEK appears at least equivalent to PK in terms of safety, efficacy, surgical risks, and complication rates, although long-term results are not yet available. The evidence also indicated that EK is superior to PK in terms of refractive stability, postoperative refractive outcomes, wound- and suture-related complications, and risk of intraoperative choroidal hemorrhage. The reduction in serious and occasionally catastrophic adverse events associated with PK has led to the rapid adoption of EK in place of PK for the treatment of corneal endothelial failure.
 
It was noted that the specific techniques are still evolving; the authors identified the following future research needs:
“Future research should be directed at assessing better surgical techniques for increasing endothelial cell survival with endothelial procedures, whether this represents new surgical techniques and/or new instrumentation…. Both new surgical techniques such as Descemet’s membrane endothelial keratoplasty and new insertion techniques must be validated by basic laboratory ex vivo studies and large, well designed cohort or randomized controlled studies and/or long-term prospective studies demonstrating complication rates and long-term endothelial cell survival.”
 
A number of studies included in the AAO review were from Chen, Terry, and colleagues at the Devers Eye Institute. One of the publications reported 6-month clinical outcomes from 100 of the first 150 consecutive eyes treated by DSAEK at this tertiary care center during 2005 and 2006 (Chen, 2008).  Fifty eyes were not available for 6-month follow-up due to illness, death, or residence out of state. Preoperatively, every patient had a diagnosis of endothelial dysfunction with clinically evident stromal edema; BCVA averaged 20/86 and uncorrected visual acuity (UCVA) averaged 20/155. Cataract surgery (n = 51) was concurrently performed if the patient had visually significant cataract or mild cataract with expectation of progression and minimal remaining accommodative amplitude. At 6-month follow-up all grafts were clear and there were no primary graft failures. There was an average gain of >4 Snellen lines with an average BCVA of 20/38. Eighty-five percent of eyes had better visual acuity than they had preoperatively, and 81% obtained vision of 20/40 or better. When patients were excluded due to other possible causes of visual loss such as macular or glaucomatous damage, BCVA improved from 20/60 to 20/30 (n=74), with an average gain of 3 Snellen lines. Eighty-eight percent of eyes in this group had better visual acuity at 6 months than they had preoperatively, and 97% of eyes had obtained a vision of 20/40 or better. The reporting of results on visual acuity did not distinguish between patients who had received concurrent cataract surgery and those whose improvements could be attributed entirely to DSAEK.
 
A search of the MEDLINE database, performed to identify additional reports published after the AAO technology assessment, identified several case reports on complications (e.g., epithelial ingrowth and adverse effects of the bubbles) as well as a number of papers on DSEK/DSAEK technique. Chen and colleagues reported the effect of training on outcomes following DSAEK (Chen, 2009).  Of 327 consecutive cases performed at their tertiary care centers during 2005–2007, 235 were performed by the attending corneal surgeon and 92 were performed by the corneal fellows. Loss to follow-up at 6 months (36% to 37%) was due to illness, death, or residence out of state. For the 208 patients who returned for the 6-month assessment, 91% of those treated by the attending surgeon and 69% of those treated by fellows had also undergone concurrent phacoemulsification for visually significant cataract at the time of DSAEK. There were no graft failures in either group, and all grafts were clear at the 6-month assessment. Dislocations and endothelial cell loss were similar in the 2 groups of patients (2% vs.1% dislocations and mean cell loss of 32% and 35%). Patients from both groups gained about 4 Snellen lines, with a 6-month average best corrected visual acuity of 20/37 and 20/36. Vision of 20/40 or better was obtained by 78% of patients treated by attending surgeons and 90% of patients treated by fellows. Vision of 20/20 or better  was obtained by 14% of patients treated by attending surgeons and 3% treated by fellows.
 
Descemet’s Membrane Endothelial Keratoplasty (DMEK)
 
Recent reviews suggest that by eliminating the stroma on the donor tissue, DMEK may reduce stromal interface haze and provide better visual acuity outcomes than DSEK/DSAEK (Dapena, 2009) (Rose, 2009).  Current literature is limited, although a review of the first 50 consecutive cases from a group in Europe suggests that a greater number of patients achieve 20/25 vision or better with DMEK (Ham, 2009).  Of the 50 consecutive eyes, 10 (20%) required a secondary DSEK for failed DMEK. For the remaining 40 eyes, 95% had a best corrected visual acuity of 20/40 or better and 75% had a best-corrected visual acuity of 20/25 or better. Donor detachments and primary graft failure with DMEK remain problematic, and the ultimate success of DMEK depends on the reliability of graft adherence and demonstrated improvement in visual acuity outcomes in comparison with DSAEK.
 
Summary
Endothelial keratoplasty, and particularly DSEK and DSAEK, are relatively new procedures. The literature at this time indicates that endothelial keratoplasty reduces the serious complications associated with penetrating keratoplasty. Specifically, visual recovery occurs much earlier, and because EK maintains an intact globe without a sutured donor cornea, astigmatism and the risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage and postoperative catastrophic wound failure are eliminated. These improvements appear to have resulted in rapid acceptance of this procedure with a trend toward intervention at an earlier stage of endothelial disease.
 
Long-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 visual loss. Due to the marked reduction in serious complications compared to the alternative, DSEK/DSAEK has become the preferred approach for endothelial dysfunction among corneal surgeons.
 
EK will continue to evolve as techniques are modified in an attempt to improve donor tissue adherence and increase endothelial survival. Randomized controlled studies and/or long-term prospective studies will be needed to adequately evaluate these new procedures.
 
Technology Assessments, Guidelines and Position Statements
 
In 2009, the Health Policy Committee of the American Academy of Ophthalmology (AAO) published a position paper on endothelial keratoplasty, stating that the optical advantages, speed of visual rehabilitation, and lower risk of catastrophic wound failure have driven the adoption of EK as the standard of care for patients with endothelial failure and otherwise healthy corneas.
 
The AAO position paper was based in large part on a comprehensive review of the literature on Descemet’s stripping automated endothelial keratoplasty (DSAEK) by the American Academy of Ophthalmology’s 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 United Kingdom’s National Institute for Health and Clinical Excellence released guidance on corneal endothelial transplantation in 2009.  The studies reviewed used DLEK, DSEK, and DSAEK. Additional data reviewed from the UK Transplant Register showed lower graft survival rates after EK than after PK; however, the difference in graft survival between the two procedures was noted to be narrowing with increased experience in EK use. The guidance concluded that “current evidence on the safety and efficacy of corneal endothelial transplantation (also know as endothelial keratoplasty [EK]) is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance and consent.” The Committee noted that techniques for this procedure continue to evolve, and thorough data collection should continue to allow future review of outcomes.
 
2010 Update
A review of the literature has been conducted through August 2010.  There was no new literature identified that would prompt a change in the coverage statement.
 
2012 Update
A literature search was conducted through May 2012.  There was no new literature identified that would prompt a change in the coverage statement.
 
2013 Update
The policy is updated with a literature search using the MEDLINE database through August 2013. The following is a summary of the key identified literature.
 
Descemet’s Stripping Endothelial Keratoplasty (DSEK) and Descemet’s Stripping Automated Endothelial Keratoplasty (DSAEK)
 
Three-year outcomes after DSAEK were reported from the Devers Eye Institute in 2012 (Li, 2012). This retrospective analysis included 108 patients who underwent DSAEK for Fuch’s endothelial dystrophy or pseudophakic bullous keratopathy and had no other ocular comorbidities. BCVA was measured at 6 months, and 1, 2, and 3 years. BCVA after DSAEK was found to improve over the 3 years of the study. For example, the percentage of patients who reached a visual acuity of 20/20 or greater was 0.9% at baseline, 11.1% at 6 months, 13.9% at 1 year, 34.3% at 2 years, and 47.2% at 3 years. Ninety-eight percent of patients reached a visual acuity of 20/40 or greater by 3 years.
 
Endothelial Keratoplasty (DMAEK)
Tourtas et al. reported a retrospective comparison of 38 consecutive patients/eyes that underwent DMEK vs. 35 consecutive patients/eyes that had undergone DSAEK (Tourtas, 2012). Only patients with Fuchs endothelial dystrophy or pseudophakic bullous keratopathy were included in the study. After DMEK, 82% of eyes required re-bubbling. After DSAEK, 20% of eyes required re-bubbling. BCVA in the 2 groups was comparable at baseline (DMEK, 0.70 logMAR and DSAEK, 0.75 logMAR). At 6-month follow-up, mean visual acuity improved to 0.17 logMAR after DMEK and 0.36 logMAR after DSAEK. This difference was statistically significant. At 6 months following surgery, 95% of DMEK-treated eyes reached a visual acuity of 20/40 or better and 43% of DSAEK-treated eyes reached a visual acuity of 20/40 or better. Endothelial cell density decreased by a similar amount after the 2 procedures (41% after DMEK and 39% after DSAEK).
 
In 2013, Van Dijk et al. reported outcomes of their first 300 consecutive eyes treated with DMEK (van Dijk, 2013). Indications for DMEK were Fuchs’ dystrophy, pseudophakic bullous keratopathy, failed PK, or failed EK. Of the 142 eyes (64%) evaluated for visual outcome at 6 months, 79% reached a BCVA of 20/25 or more and 46% reached a BCVA of 20/20 or more. Endothelial cell density measurements at 6 months were available in 251 eyes, with an average cell density of 1674 cells/mm2, a decrease of 34.6% from preoperative donor cell density. The major postoperative complication in this series was graft detachment requiring re-bubbling or re-graft, which occurred in 10.3% of eyes. Allograft rejection occurred in 3 eyes (1%). Twenty eyes (6.7%) had an elevation of intraocular pressure. Except for 3 early cases that may have been prematurely re-grafted, all but 1 eye with an attached graft cleared in 1-12 weeks.
 
A North American group reported 3-month outcomes from a prospective consecutive series of 60 cases of DMEK in 2009. In 2011, they reported 1 year outcomes from these 60 cases plus an additional 76 cases of DMEK (Price, 2009; Guerra, 2011). Preoperative BCVA averaged 20/65 (range of 20/20 to counting fingers). Sixteen eyes were lost to follow-up and 12 grafts (8.8%) had failed. For the 108 grafts that were examined and found to be clear at 1 year, 98% achieved BCVA of 20/30 or better. Endothelial cell loss was 31% at 3 months and 36% at 1 year. Although visual acuity outcomes appeared to be improved over a DSAEK series from the same investigators, preparation of the donor tissue and attachment of the endothelial graft were found to be more challenging. A 2012 cohort study by this group found reduced transplant rejection with DMEK (Anshu, 2012). One patient (0.7% of 141) in the DMEK group had a documented episode of rejection compared with 54 (9% of 598) in the DSEK group and 5 (17% of 30) in the PK group.
 
Femtosecond Laser-Assisted Corneal Endothelial Keratoplasty (FLEK)
In 2009, Cheng et al. reported a multicenter randomized trial from Europe that compared FLEK with PK (Cheng, 2009). Eighty patients with Fuchs’ endothelial dystrophy, pseudophakic bullous keratopathy, or posterior polymorphous dystrophy, and best spectacle-corrected visual acuity lower than 20/50, were included in the study. In the FLEK group, 4 of the 40 eyes did not receive the treatment due to significant preoperative events and were excluded from the analysis. Eight eyes failed (22% of 36), and 2 patients were lost to follow-up due to death in the FLEK group. Only 1 patient was lost to follow-up in the PK group due to health issues. At 12 months postoperatively, refractive astigmatism was lower in the FLEK group than the PK group (86% vs. 51%, respectively, with astigmatism <3.0D), but there was greater hyperopic shift. Mean best corrected visual acuity was better following PK than FLEK at 3-, 6-, and 12-month follow-up. There was greater endothelial cell loss in the FLEK group (65%) than 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.
 
A small retrospective cohort study from 2013 found a reduction in visual acuity when the endothelial transplant was prepared with laser (FLEK: 0.48 logMAR, n=8) compared with microtome (DSAEK: 0.33 logMAR, n=14) (Vetter, 2013). There was also greater surface irregularity with the laser-assisted EK.
 
Summary
Endothelial keratoplasty, and particularly DSEK, DSAEK, DMEK and DMAEK, are relatively new procedures. FLEK and FELEK have been reported as alternative ways to prepare the donor endothelium. The literature and clinical input available at this time indicates that endothelial keratoplasty reduces the serious complications associated with penetrating keratoplasty. Specifically, visual recovery occurs much earlier, and because EK maintains an intact globe without a sutured donor cornea, astigmatism and the risk of severe, sight-threatening complications such as expulsive suprachoroidal hemorrhage and postoperative catastrophic wound failure are eliminated. These improvements appear to have resulted in rapid acceptance of this procedure with a trend toward intervention at an earlier stage of endothelial disease.
 
Long-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 visual loss. Due to the marked reduction in serious complications compared to the alternative, DSEK/DSAEK has become the preferred 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. FLEK and FELEK have not been shown to have improved outcomes compared to existing techniques.
 
EK will continue to evolve as techniques are modified in an attempt to improve donor tissue adherence and increase endothelial survival. Randomized controlled studies and/or long-term prospective studies will be needed to adequately evaluate these new procedures.
 
2014 Update
A literature search was conducted using the MEDLINE database through August 2014. There was no new literature identified that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted using the MEDLINE database through August 2015 did not reveal any new information that would prompt a change in the coverage statement.    
 
Heinzelmann and colleagues reported on outcomes in patients who underwent EK or PK for Fuchs endothelial dystrophy or bullous keratopathy (Heinzelmann, 2016). The study included 89 eyes undergoing DSAEK and 329 eyes undergoing PK. Postoperative visual improvement was faster after EK than after PK. For example, among patients with Fuchs endothelial dystrophy, 50% of patients achieved a BCVA of Snellen 6/12 or more 18 months after DSAEK versus more than 24 months after PK. Endothelial cell loss was similar after EK or PK in the early postoperative period. However, after an early decrease, endothelial cell loss stabilized in patients who received EK whereas the decrease continued in those who had PK. Among patients with Fuchs endothelial dystrophy, there was a slightly increased risk of late endothelial failure in the first 2 years with EK than with PK. Graft failure was lower after bullous keratopathy than after Fuchs endothelial dystrophy (numbers not reported).
 
Longer term outcomes were reported in several studies. Five-year outcomes from a prospective study conducted at the Mayo Clinic were published in 2016 by Wacker and colleagues. (Wacker, 2016).  The study included 45 participants (52 eyes) with Fuchs endothelial corneal dystrophy who underwent Descemet stripping endothelial keratoplasty (DSEK). Five-year follow-up was available for 34 (65%) eyes. Mean high-contrast BCVA was 20/56 Snellen equivalent presurgery, and decreased to 20/25 Snellen equivalent at 60 months. The difference in high-contrast BCVA at 5 years versus presurgery was statistically significant (p<0.001). Similarly, the proportion of those with BCVA of 20/25 Snellen equivalent or better increased from 26% at 1 year postsurgery to 56% at 5 years (p<0.001). There were 6 graft failures during the study period (4 failed to clear after surgery, 2 failed during follow-up). All patients with graft failures were regrafted.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2018. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
65756Keratoplasty (corneal transplant); endothelial
65757Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure)

References: American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Cornea and Anterior Segment Disorders Panel.(2009) Safety and efficacy of Descemet’s stripping automated endothelial keratoplasty (DSAEK). Ophthalmology, 2009, in press.

Anshu A, Price MO, Price FW, Jr.(2012) Risk of corneal transplant rejection significantly reduced with Descemet's membrane endothelial keratoplasty. Ophthalmology 2012; 119(3):536-40.

Chen ES, Terry MA, Shamie N et al.(2008) Descemet-stripping automated endothelial keratoplasty: six month results in a prospective study of 100 eyes. Cornea 2008; 27(5):514-20.

Chen ES, Terry MA, Shamie N et al.(2009) Endothelial keratoplasty: vision, endothelial survival, and complications in a comparative case series of fellows vs attending surgeons. Am J Ophthalmol 2009;148(1):26-31.e2.

Cheng YY, Schouten JS, Tahzib NG et al.(2009) Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial. Transplantation 2009; 88(11):1294-302.

Dapena I, Ham L, Melles GR.(2009) Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol 2009; 20(4):299-307.

Eye Bank Association of America.(2007) Eye banking statistical report. Available at: http://www.restoresight.org/.

Guerra FP, Anshu A, Price MO et al.(2011) Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology 2011; 118(12):2368-73.

Ham L, Dapena I, van Luijk C et al.(2009) Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye. 2009 Jan 30. [Epub ahead of print]

Heinzelmann S, Bohringer D, Eberwein P, et al.(2016) Outcomes of Descemet membrane endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty and penetrating keratoplasty from a single centre study. Graefes Arch Clin Exp Ophthalmol. Jan 7 2016. PMID 26743748

Li JY, Terry MA, Goshe J et al.(2012) Three-year visual acuity outcomes after Descemet's stripping automated endothelial keratoplasty. Ophthalmology 2012; 119(6):1126-9.

Rose L, Kelliher C, Jun AS.(2009) Endothelial keratoplasty: historical perspectives, current techniques, future directions. Can J Ophthalmol 2009; 44(4):401-5.

Tourtas T, Laaser K, Bachmann BO et al.(2012) Descemet membrane endothelial keratoplasty versus descemet stripping automated endothelial keratoplasty. Am J Ophthalmol 2012; 153(6):1082-90 e2.

van Dijk K, Ham L, Tse WH et al.(2013) 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.

Vetter JM, Butsch C, Faust M et al.(2013) Irregularity of the posterior corneal surface after curved interface femtosecond laser-assisted versus microkeratome-assisted descemet stripping automated endothelial keratoplasty. Cornea 2013; 32(2):118-24.

Wacker K, Baratz KH, Maguire LJ, et al.(2016) Descemet stripping endothelial keratoplasty for fuchs' endothelial corneal dystrophy: five-year results of a prospective study Ophthalmology. Jan 2016;123(1):154-160. PMID 26481820


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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