Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752020
• Other study ID #: 2020P002755
• Status: Completed
• Phase: Early Phase 1
• Start date: March 28, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 30, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Fuchs corneal dystrophy

Exclusion Criteria:

• Women of childbearing potential

• Other corneal eye diseases

• Non-compliance with netarsudil

• Intolerance of netarsudil

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Netarsudil Ophthalmic
Use of netarsudil after Descemetorhexis without endothelial keratoplasty

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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