PSLT Compared to Prostaglandin Analogue Eye Drops

Not Applicable

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Prostaglandin analogue eye drops; Procedure: PSLT

• Registration Number: NCT05241938
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostaglandin analogue eye drops	Prostaglandin analogue eye drops	Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed
Pattern Selective Laser Trabeculoplasty	PSLT	PSLT will be performed using the Pascal Streamline 577 laser (Topcon Inc., Tokyo, Japan). The laser spot is directed at the anterior chamber angle encompassing the pigmented and non-pigmented trabecular meshwork. Laser power is titrated by placing a laser mark in the lower quadrant with an exposure duration of 10 milliseconds (ms). The initial energy of 500 megawatts (mW) is selected and the power is reduced or increased until a slight whitening of the trabecular meshwork is minimally noticed. This power is then maintained and the pulse duration is automatically reduced to 5ms to produce invisible injury. The treatment is administered in 32 steps, each pattern consists of 36 stitches: 3 rows of 13 stitches each (total of 1152), with zero space between adjacent stitches.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure change	1 week, 2 months, 9 months, 12 months	Intra-ocular pressure change will be similar in both groups

Secondary Outcome Measures

Name	Time	Method
Functional damage	1 week, 9 months, 12 months	Changes in visual function as measured by computerized perimetry will be assessed
Structural damage	1 week, 9 months, 12 months	Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed

Trial Locations

Locations (1)

Universidade Federal do Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil