Skip to main content
OpenTrials
Completed

NCT Number: NCT05772780

MP-3 Biofeedback Training and Central Vision Loss

The objectives of this investigation are:

* evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing; * compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age related macular degeneration

Exclusion criteria

  • Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days

Treatment and study plan

MP-3 microperimeter

Device

Biofeedback stimulation two days a week

Primary outcomes

  1. Fixation stability

    Time frame: 6 months

    Achievement of a stable fixation, defined according to Fuji classification (Stable: if more than 75% of the fixation points are inside a 2° diameter circle that has as a center the centroid of all fixation points) and the Bivariate Contour Ellipse Area, were selected as primary outcomes.

  2. Reading speed

    Time frame: 6 months

    Achievement of good reading speed: higher than 87 words per minutes was defined as our secondary outcome. Parameters for words per minutes are referred to visually impaired functional reading reported in literature

Sponsors and collaborators

Lead sponsor

Amore Filippo

Other

Registry information

Official study title

The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.