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Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

NCT05976139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-28

No results posted yet for this study

Summary

The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy.

Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated.

Evaluations of treatment effects will include:

* comprehensive ophthalmologic examination
* multifocal electroretinogram
* OCT examination
* OCT-angiography examination
* retinography

Primary endpoint.

\- central retinal thickness, measured by OCT

Conditions

  • Macular Edema
  • Inherited Retinal Dystrophy
  • Laser Retinopathy

Interventions

DEVICE

subthreshold treatment with micropulsed laser

The laser instrument used is the Q 577® Laser System, Iridex, wavelength 577 yellow. The standard pattern used is: * Power: 5% Duty Cycle * Power 250 mw * Pulse duration 200 ms * Spot size 100 micron * Pattern spacing 0.0 confluente, griglie 7x7

Sponsors & Collaborators

  • Fondazione G.B. Bietti, IRCCS

    lead OTHER

Principal Investigators

  • Lucia Ziccardi, MD, PhD · IRCCS Fondazione G.B. Bietti

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2025-07-30
Completion
2025-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976139 on ClinicalTrials.gov