search
Back to results

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

Primary Purpose

Myopia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroVision's NVC treatment for Low Myopia
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Myopia, NeuroVision, Visual acuity, Contrast sensitivity

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • College of Optometry, The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A

B

Arm Description

NeuroVision's NVC treatment for low myopia

The subjects in this group will serve as controls and will be the no intervention group.

Outcomes

Primary Outcome Measures

Visual Acuity
Contrast Sensitivity Function

Secondary Outcome Measures

Refractive Error

Full Information

First Posted
May 3, 2007
Last Updated
August 28, 2018
Sponsor
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT00469612
Brief Title
Evaluating NeuroVision's Neural Vision Correction (NVC) Myopia Treatment
Official Title
Evaluating the Efficacy of NeuroVisions's NVC Treatment for Low Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to lack of resources on part of investigators.
Study Start Date
June 2007 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: Is there an improvement in vision following the treatment without bringing about a change in the subject's prescription for glasses? Can any treatment effect be seen at 6 months and 12 months after the termination of the treatment?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, NeuroVision, Visual acuity, Contrast sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
NeuroVision's NVC treatment for low myopia
Arm Title
B
Arm Type
No Intervention
Arm Description
The subjects in this group will serve as controls and will be the no intervention group.
Intervention Type
Device
Intervention Name(s)
NeuroVision's NVC treatment for Low Myopia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Acuity
Time Frame
Every 5th visit
Title
Contrast Sensitivity Function
Time Frame
Every 5th visit
Secondary Outcome Measure Information:
Title
Refractive Error
Time Frame
Every 10th visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: The recommended pace for the treatment sessions is at least 3 sessions per week. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald O Mutti, OD, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Optometry, The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8116270
Citation
Polat U, Sagi D. The architecture of perceptual spatial interactions. Vision Res. 1994 Jan;34(1):73-8. doi: 10.1016/0042-6989(94)90258-5.
Results Reference
background
PubMed Identifier
8506641
Citation
Polat U, Sagi D. Lateral interactions between spatial channels: suppression and facilitation revealed by lateral masking experiments. Vision Res. 1993 May;33(7):993-9. doi: 10.1016/0042-6989(93)90081-7.
Results Reference
background
PubMed Identifier
8108388
Citation
Polat U, Sagi D. Spatial interactions in human vision: from near to far via experience-dependent cascades of connections. Proc Natl Acad Sci U S A. 1994 Feb 15;91(4):1206-9. doi: 10.1073/pnas.91.4.1206.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs