NCT05241938

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

January 27, 2022

Last Update Submit

February 11, 2022

Conditions

Open Angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure change

    Intra-ocular pressure change will be similar in both groups

    1 week, 2 months, 9 months, 12 months

Secondary Outcomes (2)

  • Structural damage

    1 week, 9 months, 12 months

  • Functional damage

    1 week, 9 months, 12 months

Study Arms (2)

Pattern Selective Laser Trabeculoplasty

EXPERIMENTAL

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

Prostaglandin analogue eye drops

ACTIVE COMPARATOR

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

Drug: Prostaglandin analogue eye drops

Interventions

PSLTPROCEDURE

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).

Also known as: Pattern Selective Laser Trabeculoplasty
Pattern Selective Laser Trabeculoplasty
Prostaglandin analogue eye dropsDRUG

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

Also known as: Topical treatment
Prostaglandin analogue eye drops

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • Helena Pakter, MD. PhD

    UFGRS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Pakter, MD, PhD

CONTACT

+55-51-991226968Hmpakter@hcpa.edu.br

Rafaela Almeida, MD

CONTACT

rafaelacamposdealmeida@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 16, 2022

Study Start

September 1, 2021

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)