RecruitingNot ApplicableNCT04847635

Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration


Sponsor

Ospedale San Raffaele

Enrollment

50 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan) and a medical device called Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) for people with laser burn of retina, macular degeneration intermediate, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)

The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.

DEVICEPascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)

The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.


Locations(3)

Massimo Nicolò

Genova, Italy

Giuseppe Querques

Milan, Italy

Mariacristina Parravano

Rome, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04847635


Related Trials