Evaluation of patients with retinitis pigmentosa receiving electric stimulation, ozonated blood, and ocular surgery in Cuba
E. L. Berson, J. F. Remulla, B. Rosner, M. A. Sandberg and C. Weigel-DiFranco
Berman-Gund Laboratory, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, USA.
OBJECTIVE: To evaluate the effect of intervention with electric
stimulation, autotransfused ozonated blood, and ocular surgery, performed
in Cuba, on the course of the common forms of retinitis pigmentosa. DESIGN:
Ocular evaluations over 6 to 8 months before and after intervention in
Cuba. SETTING: Evaluations performed at a US clinical research facility.
PATIENTS: Ten adult patients aged 25 to 67 years with retinitis pigmentosa.
MAIN OUTCOME MEASURES: Visual acuity, visual field area, and
electroretinogram (ERG) amplitude. RESULTS: No significant change in visual
acuity or visual field area was observed on average between preintervention
and postintervention values over a 6- to 8-month interval. Mean 30-Hz cone
ERG amplitude declined by 15.5% between preintervention and
postintervention values (P = .006). When data on change in visual field
area from 1 statistically significant outlier were excluded from the
analysis, a significant decline of 12.9% in mean visual field area was
observed (P = .025). CONCLUSIONS: These data support the conclusion that
the intervention offered in Cuba provides no benefit to patients with
retinitis pigmentosa as measured by visual acuity, visual field area, and
ERG. The magnitudes of the mean declines observed in ERG amplitude and
visual field area over a 6- to 8-month interval, relative to those reported
in previous studies, raise the possibility that this intervention may
worsen the course of the disease.