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Original Investigation
May 2, 2019

Effect of Unilateral Endothelial Keratoplasty on Vision-Related Quality-of-Life Outcomes in the Descemet Endothelial Thickness Comparison Trial (DETECT): A Secondary Analysis of a Randomized Clinical Trial

Author Affiliations
  • 1Department of Ophthalmology, California Pacific Medical Center, San Francisco
  • 2Casey Eye Institute, Oregon Health Sciences University, Portland
  • 3Byers Eye Institute, Stanford University, Palo Alto, California
  • 4Francis I. Proctor Foundation, University of California, San Francisco
  • 5Department of Ophthalmology, University of California, San Francisco
JAMA Ophthalmol. 2019;137(7):747-754. doi:10.1001/jamaophthalmol.2019.0877
Key Points

Question  Do unilateral ultrathin Descemet stripping automated endothelial keratoplasty and Descemet membrane endothelial keratoplasty affect vision-related quality of life?

Findings  In this secondary analysis of a randomized clinical trial, no significant differences in patient-reported quality of life outcomes at 3 and 12 months between the 2 groups were noted, with both groups experiencing substantially improved outcomes after unilateral endothelial keratoplasty.

Meaning  Despite a greater improvement in visual acuity, improvement in patient-reported vision-related quality of life was not shown to be greater with Descemet membrane endothelial keratoplasty compared with ultrathin Descemet stripping automated endothelial keratoplasty.

Abstract

Importance  Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life.

Objective  To determine the effect of UT-DSAEK and DMEK on vision-related quality of life.

Design, Setting, and Participants  A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy.

Interventions  Study eyes were randomized to receive either UT-DSAEK or DMEK.

Main Outcomes and Measures  Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis.

Results  There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3; P < .001), and an 11.6-point improvement at 12 months compared with baseline (n = 26; 95% CI, 6.8-16.4; P < .001). Eyes randomized to DMEK had 0.9 points more improvement in NEI VFQ-39 composite score at 3 months compared with UT-DSAEK after controlling for baseline NEI VFQ-39 (95% CI, −6.2 to 8.0; P = .80).

Conclusions and Relevance  Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK.

Trial Registration  ClinicalTrials.gov identifier: NCT02373137

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