Michael J Ang1, Winston Chamberlain2, Charles C Lin3, Julia Pickel4, Ariana Austin4, Jennifer Rose-Nussbaumer4,5. 1. Department of Ophthalmology, California Pacific Medical Center, San Francisco. 2. Casey Eye Institute, Oregon Health Sciences University, Portland. 3. Byers Eye Institute, Stanford University, Palo Alto, California. 4. Francis I. Proctor Foundation, University of California, San Francisco. 5. Department of Ophthalmology, University of California, San Francisco.
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.
RCT Entities:
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.
Authors: Grace E Dunbar; Michael Titus; Joshua D Stein; Tomas E Meijome; Shahzad I Mian; Maria A Woodward Journal: Cornea Date: 2021-10-01 Impact factor: 3.152
Authors: Suryan L Dunker; Mor M Dickman; Robert P L Wisse; Siamak Nobacht; Robert H J Wijdh; Marjolijn C Bartels; N E Mei-Lie Tang; Frank J H M van den Biggelaar; Pieter J Kruit; Bjorn Winkens; Rudy M M A Nuijts Journal: Acta Ophthalmol Date: 2021-01-12 Impact factor: 3.761