Micropulsed Laser Trabeculoplasty Using Different Parameters

Sponsor
University of Modena and Reggio Emilia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04900142
Collaborator
(none)
50
2
2
27
25
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Micropulsed laser trabeculoplasty
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Micropulsed Laser Trabeculoplasty: a Randomized Double Blinded Clinical Trial Using Different Parameters
Actual Study Start Date :
Mar 20, 2020
Anticipated Primary Completion Date :
Mar 20, 2022
Anticipated Study Completion Date :
Jun 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. IOP lowering effect [Up to six months]

    Using a tonometer, we will evaluate the difference in intraocular pressure between baseline and after the treatment. The values will be expressed in mmHg.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Primary open angle glaucoma

  • Pigmentary glaucoma

  • Pseudoexfoliative glaucoma

Exclusion Criteria:
  • Secondary glaucoma

  • Previous glaucoma surgery

  • Severely decompensated glaucoma

  • Corneal endothelial disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Policlinico di Modena Modena Italy 41124
2 Policlinico di Modena Modena Italy

Sponsors and Collaborators

  • University of Modena and Reggio Emilia

Investigators

  • Study Director: Mastropasqua Rodolfo, MD, Professor, Policlinico di Modena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gian Maria Cavallini, Associate Professor, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT04900142
Other Study ID Numbers:
  • 1152/2019/DISP/AOUMO
First Posted:
May 25, 2021
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021