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Efficacy of the ROCK inhibitor for corneal endothelial protection in Fuchs' endothelial corneal dystrophy after cataract surgery

Efficacy of the ROCK inhibitor for corneal endothelial protection in Fuchs' endothelial corneal dystrophy after cataract surgery

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220602005
Enrollment
56
Registered
2022-06-02
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endothelial cell loss in cataract surgery in Fuchs endothelial corneal dystrophy endothelial cell loss in cataract surgery in Fuchs endothelial corneal dystrophy

Interventions

post phacoemulsification eye drop : ripasudil,post phacoemulsification eye drop : placebo
Placebo Comparator Drug,Placebo Comparator Drug
ripasudil group,placebo

Sponsors

THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 40-90 years old 2. Diagnosis of FECD with modified Krachmer grade 1-4 and visual significance cataract with eligible for phacoemulsification with intraocular lens implantation 3. Central endothelial cell count > 1,000 cell/mm2 4. Paracentral endothelial cell count > 1,000 cell/mm2 in all superior /inferior/nasal/temporal quadrant 5. Central corneal thickness < 640 micron 6. Cataract grading: nuclear hardness graded by the Emery-Little classification 1-3 7. Willingness to regular follow-up as appointed

Exclusion criteria

Exclusion criteria: 1. History of severe ocular trauma with lens subluxation 2. Corneal scar 3. History of corneal laser vision correction 4. Use of ripasudil before enrollment in the study 5. Active allergy, infection, inflammation at ocular surface 6. Unstable systemic diseases: uncontrolled HT, uncontrolled DM, stroke, coronary artery disease, cerebrovascular disease, bleeding diathesis 7. History of allergy to ripasudil 8. Phacoemulsification with major intraoperative complication such as large posterior capsular tear or zonule dialysis more than 90 degrees

Design outcomes

Primary

MeasureTime frame
% Endothelial cell loss 6 months after surgery specular microscopy

Secondary

MeasureTime frame
central corneal thickness 6 months after surgery ultrasound pachymetry

Countries

Thailand

Contacts

Public ContactBenjama Keeratidamkerngsakul

Chulalongkorn University

benjamy001@gmail.com0876812185

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026