Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03483402

Enrollment

Registered

2018-03-30

Start date

2016-12-31

Completion date

2018-04-02

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-angle Glaucoma, Pseudoexfoliation Glaucoma

Keywords

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

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.

Interventions

PROCEDUREMicropulse 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single-center, one-arm, prospective clinical trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026