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MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in AMD

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
biofeedback training
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Age Related Macular Degeneration

Eligibility Criteria

56 Years - 89 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • We enrolled 30 patients (18 women and 12 men), ranging in age from 56-89 with a mean of 76.38 ±8.77, bilaterally affected by neovascular AMD from the Medical Retina Unit of the Department of Ophthalmology, University La Sapienza of Rome, Polo Pontino, A. Fiorini Hospital from August 2009 to July 2010.

Diagnosis of neovascular AMD was based on a complete ophthalmological examination including anterior and posterior segment biomicroscopy, Fluorescein Angiography (Heidelberg HRA2 FA module Heidelberg Germany), spectral domain OCT (Heidelberg HRA-2 OCT module Heidelberg Germany), microperimetry with MP-1 (NIDEK Technologies Padua Italy).

Exclusion Criteria:

  • Patients with other eye diseases (i.e. glaucoma, myopia, retinal detachment, etc), uncooperative patients and patients with media opacities were excluded.

Sites / Locations

  • University La Sapienza

Outcomes

Primary Outcome Measures

improvement of visual acuity

Secondary Outcome Measures

improvement of retinal sensitivity

Full Information

First Posted
November 17, 2010
Last Updated
November 17, 2010
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01243645
Brief Title
MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in AMD
Official Title
MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in Age Related Macular Degeneration (AMD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Biofeedback techniques have demonstrated their uselfulness in the treatment of maculopathies. We wanted to evaluate the efficacy of visual rehabilitation by means of two different types of biofeedback techniques in patients with age related macular degeneration (AMD). Methods: 30 patients bilaterally affected by AMD were enrolled with a mean age of 76,38±8,77 yrs. Patients were randomly divided in two groups: Group A was treated with an acoustic biofeedback, Group B with luminous biofeedback of a black and white checkerboard flickering during the examination. All patients underwent a complete ophthalmological examination. Rehabilitation consisted in 12 training sessions of 10 minutes for each eye performed once a week for both groups. Statistical analysis was performed using t- test. P values less than 0.05 were considered statistically significant. Results: Group A: visual acuity at the end of rehabilitation had improved, but this result was not statistically significant (p=0.054), reading speed showed a significant statistical improvement (p=0.031), as well as the fixation stability (p=0.0023) and single point mean retinal sensitivity value (p=0.044). Group B: visual acuity improvement at the end of rehabilitation was statistically significant (p=0.048), reading speed showed a statistically significant improvement (p=0.024), as well as fixation stability (p=0.0012) and mean single point retinal sensitivity value (p=0.027). Final results for both groups were compared and patients in group B showed results which were statistically more significant. Conclusion: A contrast rich flickering biofeedback stimulus showed a statistically significant improvement in training the patients to modify their preferred retinal locus (PRL) in comparison to acoustic biofeedback. It is possible that increased involvement of the various retinal cell populations with visual stimuli create more efficient ganglion cell response that better utilize the residual retinal function.

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

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
biofeedback training
Primary Outcome Measure Information:
Title
improvement of visual acuity
Secondary Outcome Measure Information:
Title
improvement of retinal sensitivity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
89 Years
Eligibility Criteria
Inclusion Criteria: We enrolled 30 patients (18 women and 12 men), ranging in age from 56-89 with a mean of 76.38 ±8.77, bilaterally affected by neovascular AMD from the Medical Retina Unit of the Department of Ophthalmology, University La Sapienza of Rome, Polo Pontino, A. Fiorini Hospital from August 2009 to July 2010. Diagnosis of neovascular AMD was based on a complete ophthalmological examination including anterior and posterior segment biomicroscopy, Fluorescein Angiography (Heidelberg HRA2 FA module Heidelberg Germany), spectral domain OCT (Heidelberg HRA-2 OCT module Heidelberg Germany), microperimetry with MP-1 (NIDEK Technologies Padua Italy). Exclusion Criteria: Patients with other eye diseases (i.e. glaucoma, myopia, retinal detachment, etc), uncooperative patients and patients with media opacities were excluded.
Facility Information:
Facility Name
University La Sapienza
City
Latina
Country
Italy
City
Rome. Latina
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22903517
Citation
Vingolo EM, Salvatore S, Limoli PG. MP-1 biofeedback: luminous pattern stimulus versus acoustic biofeedback in age related macular degeneration (AMD). Appl Psychophysiol Biofeedback. 2013 Mar;38(1):11-6. doi: 10.1007/s10484-012-9203-4.
Results Reference
derived

Learn more about this trial

MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in AMD

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