- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752020
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart.
Upon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes.
A retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Emma Davies, MD
- Phone Number: 617-523-7900
- Email: emma_davies@meei.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02127
- Massachusetts Eye and Ear Infirmary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fuchs corneal dystrophy
Exclusion Criteria:
- Women of childbearing potential
- Other corneal eye diseases
- Non-compliance with netarsudil
- Intolerance of netarsudil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Netarsudil use
Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance
|
Use of netarsudil after Descemetorhexis without endothelial keratoplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in central corneal pachymetry over time
Time Frame: Measured at post-operative month one visit and then every 2 months for 1 year
|
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
Time Frame: Measured at post-operative month one visit and then every 2 months for 1 year
|
Central endothelial cell count by specular microscopy
|
Measured at post-operative month one visit and then every 2 months for 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emma Davies, MD, Massachusetts Eye and Ear Infirmary
- Principal Investigator: Sila E Bal, MD, MPH, Massachusetts Eye and Ear Infirmary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P002755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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