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

March 7, 2022 updated by: Laurence Postelmans, Brugmann University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective study including 23 files of patients treated with the Navilas ® micropulse laser, in the period from 04/25/2018 to 11/10/2020

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Macular edema
Other: Data extraction from medical files
Data extraction from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: Baseline versus three months after treatment
Baseline versus three months after treatment
Retinal thickness change
Time Frame: Baseline versus three months after treatment
Baseline versus three months after treatment
Periodicity of anti-VEGF injections
Time Frame: Baseline versus three months after treatment
Baseline versus three months after treatment
Scar - assessed by optical coherence tomography
Time Frame: Three months after treatment
Three months after treatment
Scar - assessed by fluorescein angiography
Time Frame: Three months after treatment
Three months after treatment
Scar - assessed by auto-fluorescence fundus images
Time Frame: Three months after treatment
Three months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Investigators

  • Principal Investigator: Roman Kemani, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 9, 2021

Primary Completion (ACTUAL)

September 22, 2021

Study Completion (ACTUAL)

September 22, 2021

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (ACTUAL)

April 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Kemani

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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