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OpenTrials
Completed

NCT Number: NCT04857099

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

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.

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Visual acuity

    Time frame: Baseline versus three months after treatment

  2. Retinal thickness change

    Time frame: Baseline versus three months after treatment

  3. Periodicity of anti-VEGF injections

    Time frame: Baseline versus three months after treatment

  4. Scar - assessed by optical coherence tomography

    Time frame: Three months after treatment

  5. Scar - assessed by fluorescein angiography

    Time frame: Three months after treatment

  6. Scar - assessed by auto-fluorescence fundus images

    Time frame: Three months after treatment

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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