Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

Not Applicable

Completed

• Conditions: Pseudoexfoliation Glaucoma; Primary Open-angle Glaucoma
• Interventions: Procedure: Micropulse laser trabeculoplasty

• Registration Number: NCT03483402
• Lead Sponsor: University Hospital of Patras

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).

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-23
• Primary Completion: 2018-03-30
• Study First Posted: 2018-03-30
• Status Verified: 2018-04
• Study Completion: 2018-04-02
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEXG treated with MLT	Micropulse laser trabeculoplasty	Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure	1, 3 and 6 months	Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT