Status:
COMPLETED
Impact of the Navilas ® Micropulse Laser Treatment for Macular Edema Within the CHU Brugmann Hospital Macular Edema
Lead Sponsor:
Brugmann University Hospital
Conditions:
Macular Edema
Eligibility:
All Genders
18+ years
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04857099
Start Date
March 9 2021
End Date
September 22 2021
Last Update
March 8 2022
Active Locations (1)
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1
CHU Brugmann
Brussels, Belgium, 1020