MP-3 Biofeedback Training and Central Vision Loss

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Device: MP-3 microperimeter

• Registration Number: NCT05772780
• Lead Sponsor: Amore Filippo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Study First Submitted: 2023-02-21
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age related macular degeneration

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	MP-3 microperimeter	Training will be performed three days a week
Group A	MP-3 microperimeter	Training will be performed for two days a week

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy