PSLT Compared to Prostaglandin Analogue Eye Drops

Computer-guided Selective Laser Trabeculoplasty (PSLT) in the Treatment of Ocular Hypertension and Open-angle Glaucoma Compared to Prostaglandin Analogue Eye Drops: a Non-inferiority Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Procedure: PSLT; Drug: Prostaglandin analogue eye drops

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena Pakter, MD, PhD; Phone Number: +55-51-991226968; Email: Hmpakter@hcpa.edu.br
• Study Contact Backup: Name: Rafaela Almeida, MD; Email: rafaelacamposdealmeida@gmail.com

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Universidade Federal do Rio Grande do Sul
      • Contact: Helena M Pakter, MD, PhD; Email: hmpakter@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pattern Selective Laser Trabeculoplasty; 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.	Procedure: PSLT; 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).; Other Names: Pattern Selective Laser Trabeculoplasty
Active Comparator: Prostaglandin analogue eye drops; Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed	Drug: Prostaglandin analogue eye drops; Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye.; Other Names: Topical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure change	Intra-ocular pressure change will be similar in both groups	1 week, 2 months, 9 months, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Helena Pakter, MD. PhD, UFGRS

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 44489320.7.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes