Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

NCT03483402 | Completed

• 1 other identifier: 58/15.02.2018/5103
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Pseudoexfoliation Glaucoma; Primary Open-angle Glaucoma

Keywords

Pseudoexfoliation Glaucoma; Primary Open-angle Glaucoma; Micropulse Laser Trabeculoplasty; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

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

  12 months

Secondary Outcomes (1)

• Intraocular Pressure

  1, 3 and 6 months

Study Arms (1)

PEXG treated with MLT

EXPERIMENTAL

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

Interventions

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.

Also known as: MLT Iridex IQ 532 laser system

PEXG treated with MLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Related Publications (1)

• Makri OE, Pallikari A, Pagoulatos D, Kagkelaris K, Kostopoulou EV, Georgakopoulos CD. Micropulse laser trabeculoplasty on pseuodexfoliation glaucoma patients under topical prostaglandin analogue monotherapy: 1-year results. Graefes Arch Clin Exp Ophthalmol. 2019 Feb;257(2):349-355. doi: 10.1007/s00417-018-4195-2. Epub 2018 Nov 28.

  PMID: 30488265 DERIVED

MeSH Terms

Conditions

Exfoliation Syndrome; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Glaucoma; Ocular Hypertension

Study Officials

• Constantine D Georgakopoulos, MD, PhD

  University of Patras, Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Model Details: Single-center, one-arm, prospective clinical trial.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: December 1, 2016
• Primary Completion: March 30, 2018
• Study Completion: April 2, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04