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

University Hospital Dubrava50 enrolled

Overview

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 bullous keratopathy? Does topical netarsudil/latanoprost affects the central corneal thickness (CCT) in patients with glaucoma and pseudophakic bullous 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 12 weeks and visit the clinic once every two weeks for checkups and tests.

Patients with glaucoma and pseudophakic bullous keratopathy will be randomly divided in two groups. Group 1 will take topical netarsudil/latanoprost 1x daily for 3 months 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 OCT (Optovue Ivue). Information about intraocular pressure and adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 12 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pseudophakic Bullous Keratopathy

Interventions

Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionDRUG

Patients with pseudophakic bullous keratopthy and glaucoma will receive topical netarsudil/latanoprost 1x daily for 12 weeks.

PlaceboDRUG

Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 12 weeks.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * both sex, * age between 40 and 90 years * pseudophakic bullous keratopathy * glaucoma Exclusion Criteria: * other anterior segment pathology (corneal opacities); * ocular surface inflammation * retinal diseases affecting visual acuity * current treatment with topical prostaglandin analogue

Locations (1)

University Hospital Dubrava

Zagreb, Croatia, Croatia

Outcomes

Primary Outcomes

Visual acuity (VA)

Visual acuity measurements using Snellen chart and converted to logMAR

Time frame: 12 weeks

Secondary Outcomes

Central corneal thickness (CCT)

CCT will be measured using OCT (Optovue iVue)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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