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PSLT Compared to Prostaglandin Analogue Eye Drops

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

PSLT

Prostaglandin analogue eye drops

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Universidade Federal do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pattern Selective Laser Trabeculoplasty

Prostaglandin analogue eye drops

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Intraocular pressure change

Intra-ocular pressure change will be similar in both groups

Secondary Outcome Measures

Structural damage

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

Functional damage

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

Full Information

NCT ID

NCT05241938

First Posted

January 27, 2022

Last Updated

February 11, 2022

Sponsor

Federal University of Rio Grande do Sul

1. Study Identification

Unique Protocol Identification Number

NCT05241938

Brief Title

PSLT Compared to Prostaglandin Analogue Eye Drops

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

December 20, 2022 (Anticipated)

Study Completion Date

December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Rio Grande do Sul

4. Oversight

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

Data Monitoring Committee

Yes

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pattern Selective Laser Trabeculoplasty

Arm Type

Experimental

Arm Description

Arm Title

Prostaglandin analogue eye drops

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PSLT

Other Intervention Name(s)

Pattern Selective Laser Trabeculoplasty

Intervention Description

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

Drug

Intervention Name(s)

Prostaglandin analogue eye drops

Other Intervention Name(s)

Topical treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular pressure change

Description

Intra-ocular pressure change will be similar in both groups

Time Frame

1 week, 2 months, 9 months, 12 months

Secondary Outcome Measure Information:

Title

Structural damage

Description

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

Title

Functional damage

Description

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

Time Frame

1 week, 9 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helena Pakter, MD, PhD

Phone

+55-51-991226968

Hmpakter@hcpa.edu.br

First Name & Middle Initial & Last Name or Official Title & Degree

Rafaela Almeida, MD

rafaelacamposdealmeida@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helena Pakter, MD. PhD

Organizational Affiliation

UFGRS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidade Federal do Rio Grande do Sul

City

Porto Alegre

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helena M Pakter, MD, PhD

hmpakter@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD

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PSLT Compared to Prostaglandin Analogue Eye Drops

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