PSLT Compared to Prostaglandin Analogue Eye Drops

Sponsor

Federal University of Rio Grande do Sul (Other)

Overall Status

Recruiting

CT.gov ID

NCT05241938

Collaborator

(none)

Enrollment

Location

Arms

15.6

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Ocular Hypertension	Procedure: PSLT Drug: Prostaglandin analogue eye drops	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intraocular pressure change [1 week, 2 months, 9 months, 12 months]
Intra-ocular pressure change will be similar in both groups

Secondary Outcome Measures

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
Functional damage [1 week, 9 months, 12 months]
Changes in visual function as measured by computerized perimetry will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal do Rio Grande do Sul	Porto Alegre	RS	Brazil

Sponsors and Collaborators

Federal University of Rio Grande do Sul

Investigators

Principal Investigator: Helena Pakter, MD. PhD, UFGRS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helena Messinger Pakter, Professor, Federal University of Rio Grande do Sul

ClinicalTrials.gov Identifier:

NCT05241938

Other Study ID Numbers:

44489320.7.0000.5327

First Posted:

Feb 16, 2022

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022