Evaluating NeuroVision's Neural Vision Correction (NVC) Myopia Treatment
Summary
The purpose of the present study is to carry out a trial to evaluate the clinical efficacy of the NeuroVision Low Myopia Treatment.
The specific questions to be answered are:
1. Is there an improvement in vision following the treatment without bringing about a change in the subject's prescription for glasses?
2. Can any treatment effect be seen at 6 months and 12 months after the termination of the treatment?
Description
Myopia and its treatment modalities are one of the widely studied areas in vision research. So far all the treatment options have been optical i.e., patients with myopia are either corrected with spectacles, contact lenses or refractive surgery to provide clear vision. NeuroVision's NVC vision correction technology will be a novel method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex (area responsible for vision in the brain). It uses a non-invasive, patient-specific treatment that purports to improve neuronal efficiency and induce improvement in the overall ability to see due to a reduction in noise and increase in signal strength. As visual perception quality depends both on the input received through the eye and the processing in the visual cortex, NeuroVision's technology is hypothesized to compensate for blurred (myopic) inputs, by enhancing neural processing.
We will conduct a clinical evaluation of the effectiveness of this system. The subject will be exposed to a set of visual stimulations (pattern with black and white lines) and visual threshold level will be obtained. The subject will look at these patterns on a computer. The treatment will be applied in successive 30-40 minute sessions, administered 2-3 times a week, for a total of 40 sessions. Every 5 sessions, subject's visual performance (visual acuity, ability to see letters of varying size, and CSF, ability to see black and white lines of varying contrast) will be tested in order to continuously monitor a subject's progress. At the end of a session, the data will be sent to the NeuroVision Web Server. Proprietary algorithmic software will analyze the patient's performance and progress and will generate the parameters for the next treatment session. The purpose of the study is to assess the effect on corrected or uncorrected visual performance following treatment.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Conditions
Myopia
Intervention
NeuroVision's NVC treatment for Low Myopia, Control - No intervention
Location
College of Optometry, The Ohio State University
Columbus
Ohio
United States
43210
Status
Completed
Source
Ohio State University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00469612
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Myopia, Degenerative
Excessive axial myopia associated with complications (especially posterior staphyloma and CHOROIDAL NEOVASCULARIZATION) that can lead to BLINDNESS.
Controlled Clinical Trial
Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Controlled Clinical Trials As Topic
Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
Scleroplasty
Plastic surgery of the SCLERA. This procedure is used frequently to prevent blindness and poor vision in patients, especially children, with MYOPIA.
Photorefractive Keratectomy
A type of refractive surgery of the CORNEA to correct MYOPIA and ASTIGMATISM. An EXCIMER LASER is used directly on the surface of the EYE to remove some of the CORNEAL EPITHELIUM thus reshaping the anterior curvature of the cornea.
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