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Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483402
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Constantinos D. Georgakopoulos, MD, PhD, 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).

Condition or disease Intervention/treatment Phase
Pseudoexfoliation Glaucoma Primary Open-angle Glaucoma Procedure: Micropulse laser trabeculoplasty Not Applicable

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.


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital of Patras
Investigators
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Principal Investigator: Constantine D Georgakopoulos, MD, PhD University of Patras, Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT03483402     History of Changes
Other Study ID Numbers: 58/15.02.2018/5103
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras:
Pseudoexfoliation Glaucoma
Primary Open-angle Glaucoma
Micropulse Laser Trabeculoplasty
Intraocular Pressure
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases