MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in AMD
|ClinicalTrials.gov Identifier: NCT01243645|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : November 18, 2010
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).
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Behavioral: biofeedback training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||MP-1 Biofeedback: Pattern Stimulus Versus Audio-feedback in Age Related Macular Degeneration (AMD)|
- improvement of visual acuity
- improvement of retinal sensitivity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243645
|University La Sapienza|
|Rome. Latina, Italy|