PSLT Compared to Prostaglandin Analogue Eye Drops

Last updated: February 11, 2022
Sponsor: Federal University of Rio Grande do Sul
Overall Status: Active - Recruiting

Phase

N/A

Condition

Open Angle Glaucoma

Glaucoma

Ocular Hypertension

Treatment

N/A

Clinical Study ID

NCT05241938
44489320.7.0000.5327
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of ocular hypertension (IOP ≥ 24 mmHg in both eyes) or diagnosis ofopen-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 withintraocular lens implantation
  • No use of systemic medications known to increase IOP

Exclusion

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 Design

Total Participants: 75
Study Start date:
September 01, 2021
Estimated Completion Date:
December 20, 2022

Study 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.

Connect with a study center

  • Universidade Federal do Rio Grande do Sul

    Porto Alegre, RS
    Brazil

    Active - Recruiting

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