Clinical trial NCT01243645: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-11-18
Sex: ALL
Minimum age (years): 56
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT

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.


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.

Primary outcomes:
measure: improvement of visual acuity
Secondary outcomes:
measure: improvement of retinal sensitivity
Other outcomes:
Locations:
city: Latina
country: Italy
facility: University La Sapienza
city: Rome. Latina
country: Italy
Study officials:
References:
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.