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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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04752020
Enrollment
25
Registered
2021-02-12
Start date
2021-03-28
Completion date
2023-12-30
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Dystrophy

Keywords

Descemetorhexis without endothelial keratoplasty

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.

Interventions

Use of netarsudil after Descemetorhexis without endothelial keratoplasty

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Fuchs corneal dystrophy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in central corneal pachymetry over timeMeasured at post-operative month one visit and then every 2 months for 1 yearCorneal thickness on clinical examination and corneal topography
Change in endothelial cell count over timeMeasured at post-operative month one visit and then every 2 months for 1 yearCentral endothelial cell count by specular microscopy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026