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OpenTrials
Completed

NCT Number: NCT04752020

Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02127, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fuchs corneal dystrophy

Exclusion criteria

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

Treatment and study plan

Netarsudil Ophthalmic

Drug

Use of netarsudil after Descemetorhexis without endothelial keratoplasty

Primary outcomes

  1. Change in central corneal pachymetry over time

    Time frame: Measured at post-operative month one visit and then every 2 months for 1 year

    Corneal thickness on clinical examination and corneal topography

  2. Change in endothelial cell count over time

    Time frame: Measured at post-operative month one visit and then every 2 months for 1 year

    Central endothelial cell count by specular microscopy

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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