MP-3 Biofeedback Training and Central Vision Loss

NCT ID: NCT05772780

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-02-09

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Training will be performed for two days a week

Group Type EXPERIMENTAL

MP-3 microperimeter

Intervention Type DEVICE

Biofeedback stimulation two days a week

MP-3 microperimeter

Intervention Type DEVICE

Biofeedback stimulation three days a week

Group B

Training will be performed three days a week

Group Type EXPERIMENTAL

MP-3 microperimeter

Intervention Type DEVICE

Biofeedback stimulation two days a week

MP-3 microperimeter

Intervention Type DEVICE

Biofeedback stimulation three days a week

Interventions

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MP-3 microperimeter

Biofeedback stimulation two days a week

Intervention Type DEVICE

MP-3 microperimeter

Biofeedback stimulation three days a week

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age related macular degeneration

Exclusion Criteria

* Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amore Filippo

OTHER

Sponsor Role lead

Responsible Party

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Amore Filippo

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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4172

Identifier Type: -

Identifier Source: org_study_id

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