Clinical summary

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CLINICAL SUMMARY

 

Thousands of clinical trial participants and customers have reported significant improvement in their vision performance by two lines on the visual acuity eye chart, and a 100% increase in contrast sensitivity, on average.

Here is a summary review of the clinical data.

2022  – Vision Development & Rehabilitation (COVD)
Damaris et al. evaluated the efficacy of RevitalVision in 45 adult amblyopic patients (ages 8-48). All subjects underwent at least 6 months of part-time occlusion therapy with no improvement prior to starting the study program. Mean distance BCVA improved significantly from 0.54 LogMAR to 0.32 LogMAR (P˂.001).

2022 Journal of Clinical Medicine
Zhong et al. evaluated the efficacy of RevitalVision in 25 children with deprivation amblyopia secondary to keratoplasty (age 8.5-12). The subjects were randomized to the treatment group, who were treated with part-time patching plus RevitalVision’s perceptual learning program, and a control group, who were treated with part-time patching only. Mean distance BCVA improved significantly in the treatment group from 0.63 LogMAR to 0.32 LogMAR. 0.31 lines in the treatment group vs 0.02 lines in the control group. CSF improved significantly in the treatment group vs the control group (P=0.001).

2021 Restorative Neurology and Neuroscience
Battaglini  et al. evaluated the efficacy of RevitalVision in 6 adult patients with albinism and bilateral amblyopia (age 11-64), vs 6 normal sight subjects. Both groups underwent RevitalVision’s therapy program. Mean distance BCVA improved significantly in the treatment group from 0.59 LogMAR to 0.38 LogMAR. 0.21 lines, with no improvement in the control group (group P=0.01).

2013 Clinical Ophthalmology
Yalcin et al. evaluated the efficacy of RevitalVision in 99 adult patients with anisometropic amblyopia (age 9-50), who were randomized to 53 patients who underwent RevitalVision therapy program, and 46 patients in the control group, who underwent placebo vision training, using computer games. Mean distance BCVA improved significantly in the treatment group from 0.42 LogMAR to 0.16 LogMAR. improving 0.26 LogMAR lines (P=0.001), vs 0.08 LogMAR (no improvement) in the control group. CSF improved significantly in the treatment group 100% in F.A.C.T sine wave, with stable results 8 months post-treatment.

2009 Vision Research
Polat et al. evaluated the efficacy of RevitalVision in 5 children with amblyopia (age 7-8) who were non-compliant with patching, or in whom patching had failed despite good compliance. For the whole group, the average improvement in BCVA was 2.12 in ETDRS lines. CSF improved significantly back to the normal range.

2004 PNAS
Polat et al. studied 54 adult amblyopic patients (age 9-55) randomized to RevitalVision treatment or a placebo vision-training program. Pretreatment visual acuity in both study arms was 0.42 LogMAR, and this improved by 2.5 lines to 20/30 in the CRT treatment group, with no improvement in the control group. Additionally, a 100% increase in CSF to within the normal range was found in the treatment group. These improvements in acuity and CSF were sustained after 12 months.

Tan et al. reported a mean improvement of 2.8 logMar lines in distance unaided visual acuity (UAVA) for 55 low myopes and a mean improvement of 1.6 logMar lines in near UAVA for the 41 presbyopes (age 41-55 years old) after completion of the RV training. The improvements were shown to be retained for at least
12 months.

Tan et al. conducted a randomized controlled trial evaluating the efficacy of RV in low myopia. The interim results presented by Tan et al, at Asia ARVO 2007 confirmed that statistically significant difference in unaided visual acuity between the masked treatment groups and suggested that completion of the RV was likely to provide the definitive evidence of efficacy and safety of RV treatment in improving visual acuity and contrast sensitivity function in adult low myopes. The results of this study correlate well with RV reported commercial results – mean improvement of 2.6 logMar lines of distance uncorrected visual acuity for low myopes, 2.0 logMar lines near unaided visual acuity for early presbyopes.

Durrie et al. evaluated seventeen patients with low myopia (up to -1.75D) and 21 patients with early presbyopia (up to +2.50D Add) in 2 clinical sites who underwent RV. Eleven myopic and 18 presbyopic patients underwent RV while 9 patients performed visual examinations only serving as a control group. Researchers found the low myopia treatment group achieved a mean improvement of 2.2 logMAR lines in UAVA. CSF improved at all spatial frequencies. In this arm of the study, the control patients did not show any significant change in vision. The early presbyopia treatment group achieved a mean improvement of 2.2 logMAR lines in near UAVA. Near UCSF also improved at all spatial frequencies. The control patients in this arm have not shown any significant change in vision. Additionally, the mean refractive error in all groups remained unchanged after treatment.

Lim et al. reported a single case of RV for the treatment low myopic regression five years after myopic LASIK. The patient improved by 2.8 lines in the right eye and 1.6 lines in the left eye following RV.

Durrie et al. conducted a prospective, randomized, multicenter placebo-controlled study comparing CRT after LASIK (“NeuroLASIK”) to sham treatment (video game) following LASIK in 98 eyes. Researchers found 0.8 Snellen lines of UAVA and 79% improvement in contrast sensitivity in the treatment group relative to a 0.28 line improvement and 52% improvement in CSF in the control group. Patients who were worse than 20/20 after LASIK improved 1.56 Snellen lines of UAVA and 90% improvement in CSF with RV relative to the 0.34 lines and 47% CSF improvement in the control group. The results suggested that patients who had worse vision improved more and that perhaps there is a cortical limit to how much a patient can improve.

 

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