Impact of the Navilas ® Micropulse Laser Treatment for Ma... | NCT04857099

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

NCT04857099

Sponsor

Brugmann University Hospital

Status

Completed

Last Update Posted

Mar 8, 2022Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Macular Edema

Interventions

Data extraction from medical files

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 9, 2021Actual

Primary Completion Date

Sep 22, 2021Actual

Completion Date

Sep 22, 2021Actual

First Submitted Date

Apr 20, 2021

First Submission Date that Met QC Criteria

Apr 20, 2021

First Posted Date

Apr 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2022

Last Update Posted Date

Mar 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Macular edema			Other: Data extraction from medical files

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data extraction from medical files	Other	Data extraction from medical files	Macular edema

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Roman Kemani	CHU Brugmann	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brugmann		Brussels		1020	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided