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

Sponsor

Brugmann University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04857099

Collaborator

(none)

Enrollment

Location

6.5

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Other: Data extraction from medical files

Study Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Retrospective Study Within the Brugmann University Hospital of the Navilas ® Micropulse Laser Treatment for Macular Edema

Actual Study Start Date :

Mar 9, 2021

Actual Primary Completion Date :

Sep 22, 2021

Actual Study Completion Date :

Sep 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Macular edema	Other: Data extraction from medical files Data extraction from medical files

Arm

Intervention/Treatment

Macular edema

Other: Data extraction from medical files

Data extraction from medical files

Outcome Measures

Primary Outcome Measures

Visual acuity [Baseline versus three months after treatment]
Retinal thickness change [Baseline versus 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 fluorescein angiography [Three months after treatment]
Scar - assessed by auto-fluorescence fundus images [Three months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Brugmann	Brussels		Belgium	1020

Sponsors and Collaborators

Brugmann University Hospital

Investigators

Principal Investigator: Roman Kemani, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laurence Postelmans, Head of the Ophtalmology Department, Brugmann University Hospital

ClinicalTrials.gov Identifier:

NCT04857099

Other Study ID Numbers:

CHUB-Kemani

First Posted:

Apr 23, 2021

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Edema

Study Results

No Results Posted as of Mar 8, 2022