Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty

ID
Name
2020P002755
Description
This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.
Trial arms
Trial start
2021-03-28
Estimated PCD
2023-06-28
Trial end
2023-12-30
Status
Completed
Phase
Early phase I
Treatment
Netarsudil Ophthalmic
Use of netarsudil after Descemetorhexis without endothelial keratoplasty
Arms:
Netarsudil use
Size
25
Primary endpoint
Change in central corneal pachymetry over time
Measured at post-operative month one visit and then every 2 months for 1 year
Change in endothelial cell count over time
Measured at post-operative month one visit and then every 2 months for 1 year
Eligibility criteria
Inclusion Criteria: * Fuchs corneal dystrophy Exclusion Criteria: * Women of childbearing potential * Other corneal eye diseases * Non-compliance with netarsudil * Intolerance of netarsudil
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-03-13

1 organization

1 product

1 indication

Organization
Massachusetts Eye and Ear Infirmary
Product
Netarsudil
Indication
Fuchs' Endothelial Dystrophy