Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05976139

Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser

Led by Fondazione G.B. Bietti, IRCCS · Updated on 2025-02-28

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of subthreshold micropulsed laser treatment to reduce macular edema in patients with inherited retinal dystrophies, a group of rare eye diseases that cause progressive vision loss. Macular edema can worsen vision in these patients, and current treatments like diuretics and injections have limitations and potential side effects. This study seeks to determine if micropulsed laser therapy, which uses low energy to avoid retinal damage, can help resolve this condition. The treatment uses a specific micropulsed laser device with defined power, pulse duration, and spot size settings. Patients receive laser treatment on the first visit, with possible repeat treatments between 3 and 12 months based on response. This prospective, open-label study enrolls patients who have persistent macular edema despite prior treatments such as diuretics or anti-VEGF injections. Participants will be followed for up to 24 months with scheduled visits at 1, 3, 6, 9, 12, 18, and 24 months after treatment. At these visits, comprehensive eye exams will be performed including OCT imaging, electroretinograms, and retinography. Researchers will measure changes in central retinal thickness and assess visual acuity, retinal function, and blood flow to evaluate treatment effects and safety over time.

CONDITIONS

Brief Title

Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with inherited retinal disease
  • Age between 18 and 80 years
  • Conclusive molecular genetic study for inherited retinal dystrophy
  • Male or female patient
  • Presence of macular oedema assessed by sd-OCT with reduction  20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection
  • Phakic and pseudophakic patients
  • Central retinal thickness  320 microns in men and  305 microns in women
  • Informed consent freely granted and acquired before the start of the study
  • Ability to understand and willingness to follow study instructions and complete required visits and procedures
Not Eligible

You will not qualify if you...

  • Patients with cataract extraction prior to 6 months
  • Patients with intraocular pressure  20 mmHg
  • Patients with retinal dystrophy of unproven genetic origin
  • Patients with diabetes
  • Patients with central serous chorioretinosis, retinal vein occlusion, or age-related degeneration
  • Patients with current or previous vitreo-retinal pathology or indication for vitreo-retinal surgery
  • Patients unable to fixate gaze at 32 cm
  • Pregnant women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 24 months

Participants receive treatment with subthreshold micropulsed laser to reduce macular oedema in inherited retinal dystrophies.

1 baseline visit and 7 follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months

Trial Site Locations

Total: 1 location

1

IRCSS Fondazione G:B:Bietti

Rome, RM, Italy, 00194

Actively Recruiting

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Research Team

L

Lucia Ziccardi, MD, PhD

F

Federica Petrocchi, Orthoptist

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Comparison of topical dorzolamide and ketorolac treatment for cystoid macular edema in retinitis pigmentosa and Usher's syndrome.

Ricardo Filipe Lemos Reis, Nuno Moreira-Gonçalves, Sérgio E Estrela Silva...

https://pubmed.ncbi.nlm.nih.gov/25428176

Bone Marrow-Derived Cell Recruitment to the Neurosensory Retina and Retinal Pigment Epithelial Cell Layer Following Subthreshold Retinal Phototherapy.

Sergio Caballero, David L Kent, Nilanjana Sengupta...

https://pubmed.ncbi.nlm.nih.gov/29049716