Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

Early Phase 1

Completed

• Conditions: Fuchs' Endothelial Dystrophy
• Interventions: Drug: Netarsudil Ophthalmic

• Registration Number: NCT04752020
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

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.

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 Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-12
• Study Start: 2021-03-28
• Primary Completion: 2023-06-28
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Fuchs corneal dystrophy

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Exclusion Criteria

• Women of childbearing potential
• Other corneal eye diseases
• Non-compliance with netarsudil
• Intolerance of netarsudil

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Netarsudil use	Netarsudil Ophthalmic	Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States