Micropulsed Laser Trabeculoplasty Using Different Parameters

Micropulsed Laser Trabeculoplasty: a Randomized Double Blinded Clinical Trial Using Different Parameters

This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. The other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°.

The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Procedure: Micropulsed laser trabeculoplasty

Detailed Description

This study is a randomized, double blinded, clinical trial. Eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma.

Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.

Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.

The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.

The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.

Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.

Secondary outcomes: decrease the number of glaucoma medications applied by the patients.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matteo Gironi, MD; Phone Number: 0594225087; Email: matteo.gironi@hotmail.it

Study Locations

• Italy
  • Modena, Italy, 41124
    • Recruiting
    • Policlinico di Modena
    • Contact: Tommaso Verdina, MD, PhD; Phone Number: +390594225047; Email: tommaso.verdina@gmail.com
    • Sub-Investigator: Bruno Battaglia, MD
    • Sub-Investigator: Matteo Gironi, MD
    • Sub-Investigator: Tommaso Verdina, MD, PhD
    • Principal Investigator: Cavallini Gian Maria, MD, Professor
    • Principal Investigator: Mastropasqua Rodolfo, MD, Professor
  • Modena, Italy
    • Recruiting
    • Policlinico di Modena
    • Contact: Matteo Gironi; Phone Number: 0594225087; Email: matteo.gironi@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary open angle glaucoma
• Pigmentary glaucoma
• Pseudoexfoliative glaucoma

Exclusion Criteria:

• Secondary glaucoma
• Previous glaucoma surgery
• Severely decompensated glaucoma
• Corneal endothelial disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1500 mW; 1500 mW of Power	Procedure: Micropulsed laser trabeculoplasty; Trabeculoplasty
Active Comparator: 1000 mW; Standard treatment, 1000 mW	Procedure: Micropulsed laser trabeculoplasty; Trabeculoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP lowering effect	Using a tonometer, we will evaluate the difference in intraocular pressure between baseline and after the treatment. The values will be expressed in mmHg.	Up to six months

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Investigators: Study Director: Mastropasqua Rodolfo, MD, Professor, Policlinico di Modena

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): June 20, 2022

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 1152/2019/DISP/AOUMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No