Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048380
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-06-26
Brief Title:
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Sponsor:
Singapore Eye Research Institute
Organization:
Singapore Eye Research Institute
Study Overview
Official Title:
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study
Detailed Description:
Patients with Fuchs Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study They will be randomly assigned into treatment or placebo group
The investigators hypothesize that the ROCK inhibitor ripasudil 04 helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED
To test the hypothesis the investigators plan to conduct a randomized clinical trial which aims to
1 Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 04
2 To identity which FED patients will most likely benefit from the use of ripasudil 04 based on pre-operative parameters
3 To monitor for any adverse effects in patients assigned to ripasudil 04
The investigators hypothesize that the ROCK inhibitor ripasudil 04 helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED
To test the hypothesis the investigators plan to conduct a randomized clinical trial which aims to
1 Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 04
2 To identity which FED patients will most likely benefit from the use of ripasudil 04 based on pre-operative parameters
3 To monitor for any adverse effects in patients assigned to ripasudil 04
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None