Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04857099
Enrollment
23
Registered
2021-04-23
Start date
2021-03-09
Completion date
2021-09-22
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

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.

Interventions

Data extraction from medical files

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Visual acuityBaseline versus three months after treatment
Retinal thickness changeBaseline versus three months after treatment
Periodicity of anti-VEGF injectionsBaseline versus three months after treatment
Scar - assessed by optical coherence tomographyThree months after treatment
Scar - assessed by fluorescein angiographyThree months after treatment
Scar - assessed by auto-fluorescence fundus imagesThree months after treatment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026