NCT04900142

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

December 19, 2020

Last Update Submit

May 20, 2021

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1500 mW

EXPERIMENTAL

1500 mW of Power

Procedure: Micropulsed laser trabeculoplasty

1000 mW

ACTIVE COMPARATOR

Standard treatment, 1000 mW

Procedure: Micropulsed laser trabeculoplasty

Interventions

Micropulsed laser trabeculoplastyPROCEDURE

Trabeculoplasty

1000 mW1500 mW

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary open angle glaucoma
  • Pigmentary glaucoma
  • Pseudoexfoliative glaucoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Policlinico di Modena

Modena, 41124, Italy

RECRUITING

Policlinico di Modena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Mastropasqua Rodolfo, MD, Professor

    Policlinico di Modena

    STUDY DIRECTOR

Central Study Contacts

Matteo Gironi, MD

CONTACT

0594225087matteo.gironi@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2020

First Posted

May 25, 2021

Study Start

March 20, 2020

Primary Completion

March 20, 2022

Study Completion

June 20, 2022

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

IT(2)