Evaluating NeuroVision's Neural Vision Correction (NVC) Myopia Treatment

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00469612
First received: May 3, 2007
Last updated: April 9, 2010
Last verified: July 2008
  Purpose

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?

Condition Intervention
Myopia
Device: NeuroVision's NVC treatment for Low Myopia
Other: Control - No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of NeuroVisions's NVC Treatment for Low Myopia

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: Every 5th visit ] [ Designated as safety issue: No ]
  • Contrast sensitivity function [ Time Frame: Every 5th visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refractive error [ Time Frame: Every 10th visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
NeuroVision's NVC treatment for low myopia
Device: NeuroVision's NVC treatment for Low Myopia

NeuroVision's NVC vision correction technology is a 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).

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 and CSF) will be tested in order to continuously monitor a subject's progress.

Other: Control - No intervention
In this group, subjects will not be given any intervention. However, similar to the intervention group, every 5th session subject's visual performance (visual acuity and CSF) will be tested in order to compare the performance with the treatment group.
No Intervention: B
The subjects in this group will serve as controls and will be the no intervention group.
Device: NeuroVision's NVC treatment for Low Myopia

NeuroVision's NVC vision correction technology is a 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).

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 and CSF) will be tested in order to continuously monitor a subject's progress.

Other: Control - No intervention
In this group, subjects will not be given any intervention. However, similar to the intervention group, every 5th session subject's visual performance (visual acuity and CSF) will be tested in order to compare the performance with the treatment group.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age should be between 18 to 59 years
  • Spherical equivalent in the worst eye should not exceed -1.5 DS and the astigmatism should not exceed -0.75 DC.
  • The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months. That is, the subject's spectacle prescription should not differ from the auto-refraction value by 0.50D.
  • Unaided visual acuity is 0.6 LogMAR or better in the eye with the poorer unaided acuity
  • Unaided visual acuity is 0.1 LogMAR or worse in the eye with better unaided acuity
  • Unaided visual acuity difference between both eyes is less than 0.3 LogMAR
  • Best-corrected visual acuity is 0.04 LogMAR or better in both eyes.
  • The subject should be aware that the study has the following features:

    1. The recommended pace for the treatment sessions is at least 3 sessions per week.
    2. Interruptions should not be longer than 2 weeks during the treatment course. Note: The subject is free to voluntarily withdraw from the study at any time.

Exclusion Criteria:

  • The subject suffers from any other visually disabling eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism
  • The subject suffers from myopia-related visual complications resulting in visual loss, including myopic macular degeneration, myopic cataract and previous or pre-existing myopic retinal detachment.
  • The subject is suffering from Diabetes Mellitus.
  • The subject suffers from Migraines
  • The subject suffers from Epilepsy
  • The subject is pregnant. (It is not recommended to include pregnant women because of the expected visual fluctuations. The NV treatment , basically using a computer, has no impact on the pregnancy.) No pregnancy testing will be done but will be identified through verbal history. The study has use of tropicamide drug (dilation drops) and proparacaine (topical anesthetic), which are a routinely used eye drop in everyday clinical practice and no adverse effects have been reported so far on pregnant women or fetus.
  • The subject has an activity limitation due to medical disorders (including migraines, seizure disorders, etc.), medications, or emotional status that might potentially impair the subject's ability to perform the treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469612

Locations
United States, Ohio
College of Optometry, The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Donald O Mutti, OD, PhD Ohio State University
  More Information

Publications:
Responsible Party: Donald O.Mutti, College of optometry, The Ohio State University
ClinicalTrials.gov Identifier: NCT00469612     History of Changes
Other Study ID Numbers: 2006H0045
Study First Received: May 3, 2007
Last Updated: April 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Myopia
NeuroVision
Visual acuity
Contrast sensitivity

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014