Topical ROCK inhibition accelerates recovery after Descemetorhexis Without Endothelial Keratoplasty (DWEK) in Fuchs endothelial corneal dystrophy: a prospective comparative clinical trial
Clinical Snapshot
PICO Framework
| P — Population | 24 eyes with mild-to-moderate Fuchs endothelial corneal dystrophy undergoing phacoemulsification |
| I — Intervention | DWEK with adjunctive topical ripasudil 0.4% four times daily for eight weeks |
| C — Comparator | DWEK alone without adjunctive therapy |
| O — Outcomes | Best-corrected visual acuity (BCVA), central corneal thickness (CCT), peripheral endothelial cell density (ECD), time to corneal clearing, optical quality, and complications over 6 months |
Bottom Line
This small randomised trial suggests that adjunctive topical ripasudil 0.4% after DWEK may accelerate visual recovery and corneal clearing in patients with mild-to-moderate Fuchs endothelial corneal dystrophy. The ripasudil group achieved better visual acuity (0.24 vs 0.36 logMAR), reduced corneal thickness, and corneal clearing 4 weeks earlier than controls. However, the study has significant limitations including small sample size (24 eyes), lack of blinding, and insufficient methodological detail. While the results are promising and align with the known mechanism of ROCK inhibitors in promoting endothelial cell function, larger multicentre trials with robust methodology are needed before this can be considered standard practice. Australian ophthalmologists should await further evidence and regulatory approval before routine implementation.
Key Findings
P Value: p < 0.05 for BCVA difference, p = 0.04 for CCT difference
Effect Size: 0.12 logMAR better BCVA in ripasudil group (0.24 ± 0.11 vs 0.36 ± 0.14)
Primary Outcome: BCVA improved significantly in both groups with faster recovery in ripasudil group
Nnt Or Sensitivity: Not calculable from available data - would require individual patient outcomes
Confidence Interval: Not reported
Clinical Application
Requires surgical expertise in DWEK technique and access to topical ripasudil DWEK is performed in Australian tertiary centres. Ripasudil not currently PBS-listed but available through Special Access Scheme. Would require TGA approval for this indication Patients with mild-to-moderate FECD undergoing cataract surgery who are candidates for DWEK procedure
Abstract
PURPOSE: To compare the clinical efficacy and recovery kinetics of Descemetorhexis Without Endothelial Keratoplasty (DWEK) performed with and without adjunctive topical ripasudil 0.4% in eyes with Fuchs endothelial corneal dystrophy (FECD). SETTING: Cornea and Refractive Surgery Services, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi, India. DESIGN: Prospective, randomized, interventional, comparative clinical study. METHODS: Twenty-four eyes with mild-to-moderate FECD underwent phacoemulsification with a standardized 4-mm central DWEK and were randomized to DWEK-alone (Group A) or DWEK + topical ripasudil 0.4% four times daily for eight weeks (Group B). Primary outcomes were changes in best-corrected visual acuity (BCVA, logMAR), central corneal thickness (CCT), and peripheral endothelial cell density (ECD) over 6 months. Secondary outcomes were time to corneal clearing, optical quality (higher-order aberrations), and complications. RESULTS: BCVA improved significantly in both groups, with faster recovery in Group B (0.24 ± 0.11 vs. 0.36 ± 0.14 logMAR at 6 months; p < 0.05). CCT decreased more rapidly in Group B (572.1 ± 27.5 µm vs. 590.2 ± 29.8 µm; p = 0.04). Peripheral ECD remained stable in Group A but showed a mild gain in Group B (p = 0.04). Group B achieved earlier corneal deturgescence (mean 8 ± 2 weeks vs. 12 ± 3 weeks). No eye in either group developed persistent edema, interface haze, or required rescue keratoplasty. CONCLUSIONS: Adjunctive topical ripasudil after DWEK accelerates endothelial recovery, corneal deturgescence, and visual rehabilitation compared with DWEK alone, without compromising safety.
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