Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

NCT ID: NCT04752020

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-28
• Study Completion Date: 2023-12-30

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.

Conditions

Fuchs' Endothelial Dystrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Netarsudil use

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

Group Type: EXPERIMENTAL

Netarsudil Ophthalmic

Intervention Type: DRUG

Use of netarsudil after Descemetorhexis without endothelial keratoplasty

Interventions

Netarsudil Ophthalmic

Use of netarsudil after Descemetorhexis without endothelial keratoplasty

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Fuchs corneal dystrophy

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Emma C. Davies, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Davies, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Sila E Bal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38780446 (View on PubMed)

Other Identifiers

2020P002755

Identifier Type: -

Identifier Source: org_study_id