Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty
Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty
1 other identifier
interventional
25
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Mar 2021
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
March 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedMarch 13, 2024
March 1, 2024
2.3 years
February 2, 2021
March 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in central corneal pachymetry over time
Corneal thickness on clinical examination and corneal topography
Measured at post-operative month one visit and then every 2 months for 1 year
Change in endothelial cell count over time
Central endothelial cell count by specular microscopy
Measured at post-operative month one visit and then every 2 months for 1 year
Study Arms (1)
Netarsudil use
EXPERIMENTALPatients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance
Interventions
Use of netarsudil after Descemetorhexis without endothelial keratoplasty
Eligibility Criteria
You may qualify if:
- Fuchs corneal dystrophy
You may not qualify if:
- Women of childbearing potential
- Other corneal eye diseases
- Non-compliance with netarsudil
- Intolerance of netarsudil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02127, United States
Related Publications (1)
Bal S, Pineda R, Davies E. Prospective Assessment of Adjuvant Netarsudil Use in Patients Undergoing Descemet Stripping Only. Cornea. 2025 Mar 1;44(3):286-290. doi: 10.1097/ICO.0000000000003578. Epub 2024 May 23.
PMID: 38780446DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma Davies, MD
Massachusetts Eye and Ear Infirmary
- PRINCIPAL INVESTIGATOR
Sila E Bal, MD, MPH
Massachusetts Eye and Ear Infirmary
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 12, 2021
Study Start
March 28, 2021
Primary Completion
June 28, 2023
Study Completion
December 30, 2023
Last Updated
March 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share