The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bulbous Keratopathy (PBK)

University Hospital Dubrava

Status: Invitation-only

Conditions: Glaucoma; Pseudophakic Bullous Keratopathy

Treatments: Drug: Placebo; Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

Study type: Observational

Funder types: Other

Identifiers

NCT06960629

2025/0327-4

Details and patient eligibility

About

The goal of this clinical trial is to learn if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy in patients with glaucoma. The main questions it aims to answer are:

Does topical netarsudil/latanoprost improves visual function in patients with glaucoma and pseudophakic bulbous keratopathy? Does topical netarsudil/latanoprost affects the central corneal thickness (CCT) in patients with glaucoma and pseudophakic bulbous keratopathy? Researchers will compare topical netarsudil/latanoprost to a placebo (a look-alike substance that contains no drug) to see if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy (PBK).

Participants will take topical netarsudil/latanoprost or a placebo every day for 3 months and visit the clinic once every two weeks for checkups and tests.

Full description

Patients with glaucoma and pseudophakic bullous keratopathy will be randomly divided in two groups. Group 1 will take topical netarsudil/latanoprost 1x daily for 1 month and group 2 will take topical placebo (artificial tear substitute) 1x daily for 3 months. Visual acuity (VA) will be evaluated using Snellen chart and converted to logarithm of the minimum angle of resolution (LogMAR). Central corneal thickness (CCT) measurements will be performed using ultrasound pacymetry (Micro Medical devices, Inc, CA). Information about adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 3 months.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: both sex, between 40 and 90 years old patients with pseudophakic bullous keratopathy and glaucoma

Exclusion Criteria: other anterior segment pathology (corneal opacities); ocular surface inflammation

Trial design

50 participants in 2 patient groups

Rock inhibitor group

Description:

Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 3 months.

Treatment:

Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

Placebo group

Description:

Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 3 months.

Treatment:

Drug: Placebo