The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy

NCT06969586 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: 2025/0327-5
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if topical ROCK inhibitors protect endothelial corneal cells in patients with glaucoma and Fuchs endothelial corneal dystrophy after cataract surgery. The main question it aims to answer is: do topical ROCK inhibitors decrease the loss of corneal endothelial cells after cataract surgery? Researchers will compare topical ROCK inhibitor to a placebo (a look-alike substance that contains no drug) Participants will: Take topical ROCK inhibitor or a placebo every day for 4 weeks after cataract surgery and visit the clinic for checkups and tests.

Conditions

Fuchs Endothelial Corneal Dystrophy; Cataract; Glaucoma

Keywords

Fuchs Endothelial Corneal Dystrophy (FECD); Rho-kinase inhibitors (ROCK); corneal edema; corneal endothelium

Outcome Measures

Primary Outcomes (1)

• Endothelial cell density (ECD)

  ECD (Endothelial Cell Density) will be determined using non contact specular microscope ( confocal endomicroscopy-530, Nidek Co, Ltd, Gamagori, Japan).

  37 days

Secondary Outcomes (1)

• Visual acuity (VA)

  37 days

Study Arms (2)

ROCK inhibitor group

Patients with Fuchs Endothelial Corneal Dystrophy and glaucoma scheduled for cataract surgery. ROCK inhibitor group will receive topical ROCK inhibitor for 30 days postoperatively.

Drug: Netarsudil 0.02% Ophthalmic Solution

Placebo group

Patients with Fuchs Endothelial Corneal Dystrophy and glaucoma scheduled for cataract surgery. ROCK inhibitor group will receive topical placebo for 30 days postoperatively.

Drug: artificial tear substitute

Interventions

Netarsudil 0.02% Ophthalmic Solution DRUG

Topical Netarsudil 0.02% 1x daily for 30 days postoperatively

ROCK inhibitor group

artificial tear substitute DRUG

Topical artificial tear substitute 1x daily for 30 days postoperatively.

Placebo group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with glaucoma and FECD scheduled for cataract surgery.

You may qualify if:

• age between 40 and 90 years;
• diagnosis of FECD and glaucoma;
• cataract grade II nuclear/cortical or posterior subcapsular (Lens Opacity Classification System III \[LOCS III\].

You may not qualify if:

• other anterior segment pathology (pseudoexfoliation syndrome, corneal opacities);
• ocular surface inflammation;
• intraoperative complications (posterior capsular rupture, vitreous loss, IOL not implanted in the capsular bag);
• previous ocular trauma or intraocular surgery

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract; Glaucoma; Corneal Edema

Interventions

netarsudil; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Josip Pavan, prof.dr.sc.

  University Hospital Dubrava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)