Efficacy of the ROCK inhibitor for corneal endothelial protection in Fuchs' endothelial corneal dystrophy after cataract surgery
- Conditions
- endothelial cell loss in cataract surgery in Fuchs endothelial corneal dystrophy
- Registration Number
- TCTR20220602005
- Lead Sponsor
- THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 56
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % Endothelial cell loss 6 months after surgery specular microscopy
- Secondary Outcome Measures
Name Time Method central corneal thickness 6 months after surgery ultrasound pachymetry