Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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 Design
Arms and Interventions
| 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 |
Drug: Netarsudil Ophthalmic
Use of netarsudil after Descemetorhexis without endothelial keratoplasty
|
Outcome Measures
Primary Outcome Measures
- Change in central corneal pachymetry over time [Measured at post-operative month one visit and then every 2 months for 1 year]
Corneal thickness on clinical examination and corneal topography
- Change in endothelial cell count over time [Measured at post-operative month one visit and then every 2 months for 1 year]
Central endothelial cell count by specular microscopy
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fuchs corneal dystrophy
Exclusion Criteria:
-
Women of childbearing potential
-
Other corneal eye diseases
-
Non-compliance with netarsudil
-
Intolerance of netarsudil
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | United States | 02127 |
Sponsors and Collaborators
- Massachusetts Eye and Ear Infirmary
Investigators
- Principal Investigator: Emma Davies, MD, Massachusetts Eye and Ear Infirmary
- Principal Investigator: Sila E Bal, MD, MPH, Massachusetts Eye and Ear Infirmary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020P002755