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Francesco Maria D'Alterio, Paolo Melillo, Valentina Di Iorio, Gaia Olivo, Anna Prinster, Arturo Brunetti, Mario Quarantelli, Francesco Testa, Francesca Simonelli; Biofeedback Rehabilitation in Patients with Stargardt disease: a randomized controlled trial.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2688.
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© ARVO (1962-2015); The Authors (2016-present)
Few previous case series studies reported data on microperimetry (MP1) biofeedback rehabilitation in macular diseases, including Stargardt disease (STGD). We performed a randomized clinical trial to evaluate the efficacy of biofeedback rehabilitation of the extrafoveal Preferred Retinal Locus (PRL) of fixation in STGD patients.
24 patients (aged 29.2±11.8 years; 8F) with ABCA4 related STGD were enrolled and randomized to treatment (TG) or control (CG) group. Inclusion criteria were: best corrected visual acuity (BCVA)≥ 1/20; age ≥8 years; no other ocular or systemic diseases. Patients who underwent ocular surgery or experimental therapy in the last 6 months were excluded. The 2 groups were homogeneous for age (TG 29.66±12.9 years; CG 28,75±11.33 years) and for disease severity (measured with Fishmann and Lois classifications). At the baseline and after 3 months patients underwent an ocular examination including: BCVA measured with ETDRS chart, reading speed (RS) and minimum print size (MPS) measured with Colenbrander Reading Chart and MP1 (NIDEK Technologies). TG underwent 12 biofeedback rehabilitation sessions of 10 min for each eye by the same operator, once a week. Outcome measures were variations between the groups in BCVA and Reading Test parameters (RS, MPS) in the dominant eye (determined by the Miles Test). Measures are presented as mean±SD. Differences in the measures were assessed by unpaired t-test (significant p-value <5%). The study adhered to the tenets of the Declaration of Helsinki and received approval by the Local Ethics Committee; each patient gave informed consent.
BCVA in TG improved (5-10 letters) in 8 patients, decreased (10 letters) in 1 patient and remained stable in 3 patients, whereas in CG remained stable in 8 patients and decreased (5-10 letters) in 4 patients. The RS on average increased in the TG (13.4±17.4 words/min) whereas it remained stable in the CG (-0.6±4.0 words/min). Moreover, after the rehabilitation patients were able to read smaller size letters (-0.5±0.6), while patients in the CG showed no improvement or worsening (-0.08±0.16). Statistical analysis showed that variations of BCVA (p=0.014), RS (p=0.013) and MPS (p=0.005) between the groups were significant.
Our findings confirm that MP1 biofeedback rehabilitation improves visual function and reading abilities, thereby ameliorating overall quality of vision in STGD patients.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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