Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema
Retrospective Study Within the Brugmann University Hospital of the Navilas ® Micropulse Laser Treatment for Macular Edema
1 other identifier
observational
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
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 9, 2021
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2021
CompletedMarch 8, 2022
March 1, 2022
7 months
April 20, 2021
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (1)
Macular edema
Interventions
Eligibility Criteria
Retrospective study including 23 files of patients treated with the Navilas ® micropulse laser, in the period from 04/25/2018 to 11/10/2020
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Brugmann
Brussels, 1020, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Kemani
CHU Brugmann
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Ophtalmology Department
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 23, 2021
Study Start
March 9, 2021
Primary Completion
September 22, 2021
Study Completion
September 22, 2021
Last Updated
March 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share