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Completed

NCT Number: NCT03483402

Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).

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Key information

Conditions

Pseudoexfoliation Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Primary Open-Angle Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.

Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.

Exclusion criteria

  • pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use
  • patients unable to present for follow up

Treatment and study plan

Micropulse laser trabeculoplasty

Procedure

Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.

Other names: MLT Iridex IQ 532 laser system

Primary outcomes

  1. Intraocular Pressure

    Time frame: 12 months

    The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.

Secondary outcomes

  1. Intraocular Pressure

    Time frame: 1, 3 and 6 months

    Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

Study of the Efficacy of a Single Session Micropulse Laser Trabeculoplasty as an Adjunctive Measure in Decreasing Intraocular Pressure in Patients Suffering From Pseudoexfoliation Glaucoma

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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