MP-3 Biofeedback Training and Central Vision Loss

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772780
• Other study ID #: 4172
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: February 9, 2022

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age related macular degeneration

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• MP-3 microperimeter
Biofeedback stimulation two days a week
• MP-3 microperimeter
Biofeedback stimulation three days a week

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Amore Filippo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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