PURPOSE: To determine whether eye bank predissected corneal grafts provide outcomes comparable to surgeon-dissected grafts for Descemet stripping automated endothelial keratoplasty (DSAEK). DESIGN: Randomized, prospective, double-masked clinical trial. METHODS: Twenty pairs of donor corneas were harvested. One cornea from each pair was randomized to be precut at an eye bank for next-day use. The surgeon dissected the fellow cornea intraoperatively using a comparable microkeratome and protocol. The corneas were randomly assigned to 40 subjects having DSAEK at a single center. Subjects and evaluators were masked and statistical significance was assessed using the paired t test. RESULTS:Mean subject age was 71 +/- 12 years and 90% had Fuchs dystrophy. Mean endothelial cell loss was 32% at six months and 34% at one year; the two groups did not differ by a statistically significant amount at either time point (P = .10 and P = .79, respectively). Each group experienced two early dislocations (10%), and grafts were repositioned successfully with a second air bubble. At six months, 28 of 35 patients (80%) had best-corrected vision of 20/40 or better, excluding five patients (12%) with preexisting retinal problems (P = .48). Both groups experienced a mild hyperopic shift (P = .82), and neither had a statistically significant increase in mean refractive cylinder (P = .63). Histology from one subject's eye postmortem demonstrated that endothelial cells had migrated over the exposed edge of the donor stroma a year after surgery. CONCLUSIONS: Eye bank precut tissue provided similar endothelial cell loss, visual and refractive outcomes, and detachment rates compared with surgeon-dissected tissue.
RCT Entities:
PURPOSE: To determine whether eye bank predissected corneal grafts provide outcomes comparable to surgeon-dissected grafts for Descemet stripping automated endothelial keratoplasty (DSAEK). DESIGN: Randomized, prospective, double-masked clinical trial. METHODS: Twenty pairs of donor corneas were harvested. One cornea from each pair was randomized to be precut at an eye bank for next-day use. The surgeon dissected the fellow cornea intraoperatively using a comparable microkeratome and protocol. The corneas were randomly assigned to 40 subjects having DSAEK at a single center. Subjects and evaluators were masked and statistical significance was assessed using the paired t test. RESULTS: Mean subject age was 71 +/- 12 years and 90% had Fuchs dystrophy. Mean endothelial cell loss was 32% at six months and 34% at one year; the two groups did not differ by a statistically significant amount at either time point (P = .10 and P = .79, respectively). Each group experienced two early dislocations (10%), and grafts were repositioned successfully with a second air bubble. At six months, 28 of 35 patients (80%) had best-corrected vision of 20/40 or better, excluding five patients (12%) with preexisting retinal problems (P = .48). Both groups experienced a mild hyperopic shift (P = .82), and neither had a statistically significant increase in mean refractive cylinder (P = .63). Histology from one subject's eye postmortem demonstrated that endothelial cells had migrated over the exposed edge of the donor stroma a year after surgery. CONCLUSIONS: Eye bank precut tissue provided similar endothelial cell loss, visual and refractive outcomes, and detachment rates compared with surgeon-dissected tissue.
Authors: Chaitanya Kolluru; Beth A Benetz; Naomi Joseph; Harry J Menegay; Jonathan H Lass; David Wilson Journal: Proc SPIE Int Soc Opt Eng Date: 2019-03-13
Authors: Mark A Terry; Anthony J Aldave; Loretta B Szczotka-Flynn; Wendi Liang; Allison R Ayala; Maureen G Maguire; Christopher Croasdale; Yassine J Daoud; Steven P Dunn; Caroline K Hoover; Marian S Macsai; Thomas F Mauger; Sudeep Pramanik; George O D Rosenwasser; Jennifer Rose-Nussbaumer; R Doyle Stulting; Alan Sugar; Elmer Y Tu; David D Verdier; Sonia H Yoo; Jonathan H Lass Journal: Ophthalmology Date: 2018-08-09 Impact factor: 12.079
Authors: Marco Lombardo; Mark A Terry; Giuseppe Lombardo; David D Boozer; Sebastiano Serrao; Pietro Ducoli Journal: Graefes Arch Clin Exp Ophthalmol Date: 2010-01-29 Impact factor: 3.117