The authors present a single-centre, prospective, randomised, comparative clinical trial (RCT) of 24 eyes of 24 patients with mild-to-moderate Fuchs endothelial corneal dystrophy (FECD) undergoing combined phacoemulsification and a standardised 4mm central descemetorhexis without endothelial keratoplasty (DWEK), with or without adjunctive topical ripasudil 0.4% 4 times daily for 8 weeks. Primary outcomes were change in best-corrected visual acuity (BCVA), central corneal thickness (CCT), and peripheral endothelial cell density (ECD) over 6 months. The ripasudil arm achieved significantly faster visual recovery (0.24 ±0.11 vs 0.36 ±0.14logMAR at 6 months; p<0.05), more rapid corneal deturgescence (mean 8 ±2 vs 12 ±3 weeks), and a modest but statistically significant gain in peripheral ECD. No eye in either arm developed persistent oedema, interface haze, or required rescue keratoplasty. The direction and magnitude of these effects align closely with the 3 prior published trials on adjunctive ROCK inhibition after DWEK, and the safety profile remains reassuring. Several methodological caveats deserve attention. The sample size is small with no a priori power calculation, and masking was limited to the specular microscopy technician rather than patients or the operating surgeon, introducing potential bias into the BCVA and clarity assessments. Notably, the authors concede that reliable central ECD measurements could not be consistently obtained, and outcomes are inferred from peripheral ECD and pachymetric proxies. The CONSORT flow diagram also contains an apparent reporting error in the group B allocation count. Despite these limitations, this trial adds the first prospective randomised data from an Indian cohort to a growing but still-small evidence base. Further larger, adequately powered, multicentre randomised trials with central endothelial imaging and longer follow-up are warranted to establish ROCK-assisted DWEK as a reliable, donor-independent alternative to endothelial keratoplasty in early FECD.
ROCK inhibition after descemetorhexis without endothelial keratoplasty: a small but timely Indian RCT
Reviewed by Ali Alseneid
Topical ROCK inhibition accelerates recovery after descemetorhexis without endothelial keratoplasty (DWEK) in Fuchs endothelial corneal dystrophy: a prospective comparative clinical trial.
