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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04857099
Other study ID # CHUB-Kemani
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2021
Est. completion date September 22, 2021

Study information

Verified date March 2022
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 22, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Data extraction from medical files
Data extraction from medical files

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuity Baseline versus three months after treatment
Primary Retinal thickness change Baseline versus three months after treatment
Primary Periodicity of anti-VEGF injections Baseline versus three months after treatment
Primary Scar - assessed by optical coherence tomography Three months after treatment
Primary Scar - assessed by fluorescein angiography Three months after treatment
Primary Scar - assessed by auto-fluorescence fundus images Three months after treatment
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