Back to resultsMP-3 Biofeedback Training and Central Vision Loss
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MP-3 microperimeter
MP-3 microperimeter
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria: Age related macular degeneration Exclusion Criteria: Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days
Sites / Locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Training will be performed for two days a week
Training will be performed three days a week
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05772780
Brief Title
MP-3 Biofeedback Training and Central Vision Loss
Official Title
The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amore Filippo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Training will be performed for two days a week
Arm Title
Group B
Arm Type
Experimental
Arm Description
Training will be performed three days a week
Intervention Type
Device
Intervention Name(s)
MP-3 microperimeter
Intervention Description
Biofeedback stimulation two days a week
Intervention Type
Device
Intervention Name(s)
MP-3 microperimeter
Intervention Description
Biofeedback stimulation three days a week
Primary Outcome Measure Information:
Title
Fixation stability
Description
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.
Time Frame
6 months
Title
Reading speed
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age related macular degeneration
Exclusion Criteria:
Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MP-3 Biofeedback Training and Central Vision Loss
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