Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

April 2, 2018 updated by: Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEXG treated with MLT
Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)
Procedure: Micropulse laser trabeculoplasty
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Investigators

  • Principal Investigator: Constantine D Georgakopoulos, MD, PhD, University of Patras, Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

April 2, 2018

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 2, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/15.02.2018/5103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Open-angle Glaucoma

Clinical Trials on Micropulse laser trabeculoplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe