Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

Primary Open-angle Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483402
• Other study ID #: 58/15.02.2018/5103
• Status: Completed
• Phase: N/A
• First received: March 23, 2018
• Last updated: April 2, 2018
• Start date: December 2016
• Est. completion date: April 2, 2018

Study information

• Verified date: April 2018
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma
• Pseudoexfoliation Glaucoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	The change in IOP at 12 months versus baseline and the percentage of patients with =20% reduction in IOP.	12 months
Secondary	Intraocular Pressure	Change in IOP and the percentage of =20% IOP reduction at 1, 3 and 6 months after MLT	1, 3 and 6 months