The British journal of ophthalmology · 2024
Visual function after ultrathin Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty combined with cataract surgery: a randomised controlled clinical trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Madsen Morten Brok Molbech, Ivarsen Anders, Hjortdal Jesper
Аннотация
AIMS: To compare best-corrected visual acuity (BCVA), contrast sensitivity and endothelial cell density (ECD) after ultrathin Descemet's stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK).
METHODS: A randomised, single-blinded, single-centre design was used. 72 patients with Fuchs' endothelial dystrophy and cataract were randomised to UT-DSAEK or DMEK combined with phacoemulsification and lens implantation. 27 patients with cataract were included in a control group and treated with phacoemulsification and lens implantation. The primary outcome was BCVA at 12 months.
RESULTS: Compared with UT-DSAEK, DMEK resulted in better BCVA with mean differences of 6.1 early treatment diabetic retinopathy study (ETDRS) (p=0.001) after 3 months, 7.4 ETDRS (p<0.001) after 6 months and 5.7 ETDRS (p<0.001) after 12 months. The control group obtained significantly better BCVA with a mean difference of 5.2 ETDRS (p<0.001) compared with DMEK 12 months postoperatively. Compared with UT-DSAEK, contrast sensitivity was significantly better 3 months after DMEK with a mean difference of 0.10 LogCS (p=0.03). However, our study found no effect after 12 months (p=0.08). ECD was significantly lower after UT-DSAEK compared with DMEK with mean differences of 332 cells/mm2 (p<0.01) after 3 months, 296 cells/mm2 (p<0.01) after 6 months and 227 cells/mm2 (p=0.03) after 12 months.
CONCLUSIONS: Compared with UT-DSAEK, DMEK resulted in better BCVA 3, 6 and 12 months postoperatively. Twelve months postoperatively, DMEK had a higher ECD than UT-DSAEK; however, no difference in contrast sensitivity was found.
TRIAL REGISTRATION NUMBER: NCT04417959.
METHODS: A randomised, single-blinded, single-centre design was used. 72 patients with Fuchs' endothelial dystrophy and cataract were randomised to UT-DSAEK or DMEK combined with phacoemulsification and lens implantation. 27 patients with cataract were included in a control group and treated with phacoemulsification and lens implantation. The primary outcome was BCVA at 12 months.
RESULTS: Compared with UT-DSAEK, DMEK resulted in better BCVA with mean differences of 6.1 early treatment diabetic retinopathy study (ETDRS) (p=0.001) after 3 months, 7.4 ETDRS (p<0.001) after 6 months and 5.7 ETDRS (p<0.001) after 12 months. The control group obtained significantly better BCVA with a mean difference of 5.2 ETDRS (p<0.001) compared with DMEK 12 months postoperatively. Compared with UT-DSAEK, contrast sensitivity was significantly better 3 months after DMEK with a mean difference of 0.10 LogCS (p=0.03). However, our study found no effect after 12 months (p=0.08). ECD was significantly lower after UT-DSAEK compared with DMEK with mean differences of 332 cells/mm2 (p<0.01) after 3 months, 296 cells/mm2 (p<0.01) after 6 months and 227 cells/mm2 (p=0.03) after 12 months.
CONCLUSIONS: Compared with UT-DSAEK, DMEK resulted in better BCVA 3, 6 and 12 months postoperatively. Twelve months postoperatively, DMEK had a higher ECD than UT-DSAEK; however, no difference in contrast sensitivity was found.
TRIAL REGISTRATION NUMBER: NCT04417959.