MP-3 Biofeedback Training and Central Vision Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Device: MP-3 microperimeter; Device: MP-3 microperimeter

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age related macular degeneration

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Training will be performed for two days a week	Device: MP-3 microperimeter; Biofeedback stimulation two days a week; Device: MP-3 microperimeter; Biofeedback stimulation three days a week
Experimental: Group B; Training will be performed three days a week	Device: MP-3 microperimeter; Biofeedback stimulation two days a week; Device: MP-3 microperimeter; Biofeedback stimulation three days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fixation stability	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.	6 months
Reading speed	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	6 months

Collaborators and Investigators

• Sponsor: Amore Filippo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 4172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No