Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty

doi:10.1016/j.ophtha.2018.05.019

Ophthalmology

Volume 126, Issue 1, January 2019, Pages 19-26

Presented in part at the American Academy of Ophthalmology Cornea Subspecialty Day 2017 on November 11, 2017. The full results presented here have been submitted for consideration as a paper or poster for the American Academy of Ophthalmology, New Orleans, Louisiana, Cornea Subspecialty Day, November 2018.

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Purpose

To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction.

Design

Patient and outcome-masked, randomized controlled clinical trial.

Participants

Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK.

Methods

Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery.

Main Outcome Measures

The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry.

Results

A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P < 0.001), and 1.4 lines better BSCVA at 12 months (95% CI, 2.2–0.7 lines better; P < 0.001). Average endothelial cell counts were 1963 cells/mm² in DMEK and 2113 cells/mm² in UT-DSAEK at 6 months (P = 0.17) and 1855 cells/mm² in DMEK and 2070 cells/mm² in UT-DSAEK at 12 months (P = 0.051). Intraoperative and postoperative complication rates were similar between groups.

Conclusions

Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

Section snippets

Trial Design

The Descemet Endothelial Thickness Comparison Trial was an institutionally funded, randomized, patient and outcome-masked, controlled clinical trial comparing the clinical outcomes of 2 types of endothelial keratoplasty. Eyes with endothelial dysfunction from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy were independently randomized in a 1:1 fashion to UT-DSAEK or DMEK.

Primary Outcome

The primary outcome of the trial was best spectacle-corrected visual acuity (BSCVA) at 6 months.

Study Participants

Enrollment

Results

A total of 216 patients with endothelial dysfunction were screened between January 20, 2015, and April 26, 2017, and 50 eyes from 38 patients were randomized to UT-DSAEK or DMEK (Fig 1). Enrollment sites included Casey Eye Institute at OHSU (N = 43 eyes, N = 31 patients; 86%) and Byers Eye Institute at Stanford University, which joined the study September 20, 2016 (N = 7 eyes, N = 7 patients; 14%). Most patients who were screened but not enrolled were excluded because they had complex anterior

Discussion

In this study, we found that DMEK provides superior visual acuity results compared with UT-DSAEK for patients with isolated endothelial dysfunction. Patients receiving DMEK had more rapid visual acuity improvement, and although those randomized to UT-DSAEK improved with time, there remained approximately 1.5 lines difference at 12 months. Several large series of DMEK outcomes have reported excellent visual acuity with low reoperation rates similar to ours; however, the majority of corneal

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To compare the outcome between posterior lamellar corneal transplant procedures for Fuchs endothelial corneal dystrophy, taking preoperative patient characteristics in consideration. Surgical methods compared were Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), and DSAEK with concomitant cataract surgery (phacoemulsification plus DSAEK).
Registry-based study with propensity score matching.
One thousand six hundred seventy-seven patients from all Swedish corneal transplantation units treated from 2012 through 2019.
All patients undergoing endothelial keratoplasty performed from 2012 through 2019 with completed 2-year follow-up data reported to The Swedish Corneal Transplant Register were included, totaling 1677 patients. Three comparable groups (DMEK, DSAEK, and phacoemulsification plus DSAEK) with 216 patients in each group were generated with propensity score matching based on preoperative visual acuity, age, sex, year of surgery, and preoperative risk factors such as inflammation, vascularization, and glaucoma.
Best-corrected visual acuity (BCVA) at the 2-year follow-up, frequency of graft dislocation, graft rejection episodes, and graft failure within 2 years including primary graft failure.
The preoperative corneal status was affected more severely in the DSAEK group before matching. In the matched groups, the median BCVA 2 years after surgery was 0.1 logarithm of the minimum angle of resolution (logMAR) in both the DMEK and the phacoemulsification plus DSAEK groups and 0.15 logMAR in the DSAEK group (P = 0.001). The frequency of graft dislocation was higher among the patients undergoing phacoemulsification plus DSAEK, but the frequency of graft failure and primary graft failure was higher in the DMEK group.
Visual acuity improved in most patients (90%) with all 3 surgical methods. However, DMEK and phacoemulsification plus DSAEK reached higher levels of visual acuity 2 years after surgery, and phacoemulsification plus DSAEK was superior considering graft survival rate. All 3 surgical procedures showed both strengths and weaknesses, suggesting that the choice of surgical method should be individualized, taking into consideration not only the cornea, but each patient’s complete medical status as well as the entire course of postoperative medical care.
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Reply to comment on: Systematic Review and Meta-Analysis: Outcomes After Descemet Membrane Endothelial Keratoplasty Versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty
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Risk factors for failure of pre-cut eye bank UT-DSAEK grafts
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Les principaux facteurs de risque d’échec des greffes transfixiantes de cornée sont bien connus dans la littérature. Cependant, peu d’études se sont intéressées aux caractéristiques du donneur et du greffon.
Il s’agit d’une étude rétrospective monocentrique au CHU de Nantes, qui avait pour but de rechercher des facteurs prédictifs d’échec ou de réussite de greffe à 1 an dans le cadre d’UT-DSAEK préparées en banque multi-tissus entre mai 2016 et octobre 2018. Le critère de jugement principal était le succès ou l’échec à 12 mois de la greffe.
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Nos résultats sont concordants avec ceux de la littérature. Cependant certains critères tels que le type de don ou la perte cellulaire endothéliale pré-greffe n’ont pas été retrouvés dans la littérature. L’UT-DSAEK a montré sa supériorité par rapport à la DSAEK mais semble rapporter des résultats un peu moindres par rapport à la DMEK.
Le principal facteur d’échec de greffe était la regreffe précoce dans les 12 mois. Cependant, la faible incidence des échecs de greffe en limite l’interprétation.
The main risk factors for graft failure in penetrating keratoplasty are well known. However, few studies have examined donor characteristics or more precise data on endothelial keratoplasty.
This was a retrospective, single-center study at the Nantes University Hospital, aiming to identify factors predictive of one-year success or failure of eye bank UT-DSAEK endothelial keratoplasty grafts prepared between May 2016 and October 2018. The outcome measure was success or failure at 12 months post keratoplasty.
One hundred and five grafts were included: 93 successes and 12 failures at 12 months. The failure rate was higher in 2016 compared to 2017 and 2018. The characteristics associated with higher failure rate were elderly donor, shorter time between harvesting and grafting, lower endothelial cell density, significant pre-graft endothelial cell loss, re-graft for Fuchs dystrophy, history of corneal transplant.
Our results are consistent with those in the literature. However, some factors, such as the type of corneal harvesting or pre-graft endothelial cell loss, were not found. UT-DSAEK has demonstrated better results than DSAEK, but still appears to be somewhat inferior to DMEK.
The main factor for graft failure in our study was an early re-graft within 12 months. However, the low incidence of graft failure limits interpretation of these results.
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Surgical innovations are necessary to improve patient care. After an initial exploratory phase, novel surgical technique should be compared with alternative options or standard care in randomized controlled trials (RCTs). However, surgical RCTs have unique methodological challenges. Our study sought to investigate key aspects of the design, conduct, and reporting of RCTs of novel surgeries.
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The protocol was prospectively registered in PROSPERO (CRD42021253297). RCTs evaluating novel surgeries for cataract, vitreoretinal, glaucoma, and corneal diseases were included. Medline, EMBASE, Cochrane Library, and Clinicaltrials.gov were searched. The search period was January 1, 2016, to June 16, 2021.
A total of 52 ophthalmic surgery RCTs were identified in the fields of glaucoma (n = 12), vitreoretinal surgery (n = 5), cataract (n = 19), and cornea (n = 16). A description defining the surgeon's experience or level of expertise was reported in 30 RCTs (57%) and was presented in both control and intervention groups in 11 (21%). Specification of the number of cases performed in the particular surgical innovation being assessed prior to the trial was reported in 10 RCTs (19%) and an evaluation of quality of the surgical intervention in 7 (13%). Prospective trial registration was recorded in 12 RCTs (23%) and retrospective registration in 13 (25%); and there was no registration record in the remaining 28 (53%) studies.
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: Financial Disclosure(s): The author(s) made the following disclosures:

: Supported by Grants K23 EY025025 (J.R.-N.) from the National Eye Institute and Research to Prevent Blindness. The eye bank Lions VisionGift of Portland, Oregon, contributed to the design and implementation of the study, providing all of the tissue for the study and randomizing all eyes to treatment arm.

: HUMAN SUBJECTS: Human subject/tissues were included. Study protocol was approved by the Human Research Committees at University of California, San Francisco, OHSU, and Stanford University. The trial conformed to the Declaration of Helsinki. Written informed consent was obtained from all participants.

: No animal subjects were used in this study.

: Trial Registration: NCT02373137.

: Author Contributions:

: Conception and design: Chamberlain, Shubach, Clover, McLeod, Lietman, Rose-Nussbaumer

: Data collection: Chamberlain, Lin, Austin, Shubach, Clover, Lietman, Rose-Nussbaumer

: Analysis and interpretation: Austin, Porco, Rose-Nussbaumer

: Obtained funding: N/A

: Overall responsibility: Chamberlain, Lin, Austin, Shubach, Clover, McLeod, Porco, Lietman, Rose-Nussbaumer

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Published by Elsevier on behalf of the American Academy of Ophthalmology

Original articleDescemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty

Purpose

Design

Participants

Methods

Main Outcome Measures

Results

Conclusions

Section snippets

Trial Design

Primary Outcome

Study Participants

Results

Discussion

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Arch Soc Esp Oftalmol

Ophthalmology

Ophthalmology

Global survey of corneal transplantation and eye banking

JAMA Ophthalmol

Evolution of endothelial keratoplasty

Cornea

Original article
Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty