Clinical Trials Directory

Trials / Completed

CompletedNCT01243645

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

MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in Age Related Macular Degeneration (AMD)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
Sponsor
University of Roma La Sapienza · Academic / Other
Sex
All
Age
56 Years – 89 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALbiofeedback training

Timeline

First posted
2010-11-18
Last updated
2010-11-18

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT01243645. Inclusion in this directory is not an endorsement.