PSLT Compared to Prostaglandin Analogue Eye Drops

NCT ID: NCT05241938

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-20

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PSLT

Intervention Type: PROCEDURE

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 drops

Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed

Group Type: ACTIVE_COMPARATOR

Prostaglandin analogue eye drops

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: PROCEDURE

Prostaglandin analogue eye drops

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

Intervention Type: DRUG

Other Intervention Names

Pattern Selective Laser Trabeculoplasty; Topical treatment

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Helena Messinger Pakter

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Pakter, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

UFGRS

Locations

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Helena Pakter, MD, PhD

Role: CONTACT

Hmpakter@hcpa.edu.br

+55-51-991226968

Rafaela Almeida, MD

Role: CONTACT

rafaelacamposdealmeida@gmail.com

Facility Contacts

Helena M Pakter, MD, PhD

Role: primary

hmpakter@hcpa.edu.br

Other Identifiers

44489320.7.0000.5327

Identifier Type: -

Identifier Source: org_study_id