PSLT Compared to Prostaglandin Analogue Eye Drops

N/AUnknownNCT05241938

Federal University of Rio Grande do Sul75 enrolled

Overview

This study aims to compare the efficacy of PSLT and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (OCT) related to pressure change resulting from treatments

Patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study. These patients will have both eyes included in the study. A randomization will be made to allocate one eye to receive treatment with PSLT (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control). Patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and OCT will be performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

PSLTPROCEDURE

PSLT will be performed under topical anesthesia (proxymetacaine hydrochloride 5mg/ml eye drops) using a mirrored gonioscopy lens (Latina Ocular Instruments). A α2 agonist hypotensive eye drops (0.2% brimonidine tartrate) and 2% pilocarpine eye drops are applied 40 minutes before the procedure. After laser treatment, the patient will be instructed to use non-steroidal anti-inflammatory eye drops (thrice daily for 7 days).

Prostaglandin analogue eye dropsDRUG

Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye.

Eligibility

Sex: ALLMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of ocular hypertension (IOP ≥ 24 mmHg in both eyes) or diagnosis of open-angle glaucoma (POAG) in both eyes * Proper visualization of angle structures and 360 degree open angles in both eyes * No previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation * No use of systemic medications known to increase IOP Exclusion Criteria: * Patients using more than two glaucoma medications * Evidence of any other eye disease that could affect IOP measurement * Diagnosis of other types of glaucoma * Patient with mean deviation (MD) less than -12 decibels (dB) on visual perimetry (severe disease) * Patients with unilateral glaucoma

Locations (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

Intraocular pressure change

Intra-ocular pressure change will be similar in both groups

Time frame: 1 week, 2 months, 9 months, 12 months

Secondary Outcomes

Structural damage

Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed

Time frame: 1 week, 9 months, 12 months

Functional damage

Changes in visual function as measured by computerized perimetry will be assessed

Time frame: 1 week, 9 months, 12 months

Central Contacts

Helena Pakter, MD, PhD

CONTACT

+55-51-991226968 Hmpakter@hcpa.edu.br

Rafaela Almeida, MD

CONTACT

rafaelacamposdealmeida@gmail.com

Data from ClinicalTrials.gov

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