Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma
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|ClinicalTrials.gov Identifier: NCT03483402|
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pseudoexfoliation Glaucoma Primary Open-angle Glaucoma||Procedure: Micropulse laser trabeculoplasty||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-center, one-arm, prospective clinical trial.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||April 2, 2018|
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 Name: MLT Iridex IQ 532 laser system
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483402
|Principal Investigator:||Constantine D Georgakopoulos, MD, PhD||University of Patras, Medical School|