Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema

Completed

• Conditions: Macular Edema

• Registration Number: NCT04857099
• Lead Sponsor: Brugmann University Hospital

Brief Summary

The Navilas® micropulse laser can be used to treat patients with macular edema and good visual acuity, which therefore do not fall within the indications for conventional treatments by intravitreal injections.

The CHU Brugmann Hospital is the only center to own this laser in Belgium.This study aims to evaluate the efficacy of this laser.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Diffuse macular edema without focal edema source accessible by focal laser (e.g. capillary telangiectasia)
• Central retinal thickness ≤ 400microns.
• Patient does not meet the reimbursement criteria for intra-vitreous injections(IVI) of anti-VEGF (eg AV> 5/10).
• IVI are contraindicated.
• Physician considers that it is preferable to space out the injections because of the side effects (eg. ocular disturbance during IVI, eye pain, sensation of a foreign body, spots in the visual field generating a visual gene etc.)
• Patient wishing to space the anti-VEGF IVI.

Exclusion Criteria

• Macular edema of a different etiology than diabetic macular edema or venous thrombosis (e.g. cataract extraction, vitreomacular traction, epiretinal membrane etc.)
• Central retinal thickness > 400 microns.
• The eye presents a focal edematous maculopathy accessible to conventional laser.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scar - assessed by fluorescein angiography	Three months after treatment
Periodicity of anti-VEGF injections	Baseline versus three months after treatment
Scar - assessed by optical coherence tomography	Three months after treatment
Scar - assessed by auto-fluorescence fundus images	Three months after treatment
Retinal thickness change	Baseline versus three months after treatment
Visual acuity	Baseline versus three months after treatment

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium