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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857099
• Other study ID #: CHUB-Kemani
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Edema
• Macular Edema

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