MP-3 Biofeedback Training and Central Vision Loss

• Sponsor: Amore Filippo (Other)
• Overall Status: Completed
• CT.gov ID: NCT05772780
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Device: MP-3 microperimeter; Device: MP-3 microperimeter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Feb 9, 2022
• Actual Study Completion Date: Feb 9, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fixation stability [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age related macular degeneration

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

• Amore Filippo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amore Filippo, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05772780
• Other Study ID Numbers: 4172
• First Posted: Mar 16, 2023
• Last Update Posted: Mar 16, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Mar 16, 2023