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

NCT00469612 | Terminated Results

• 1 other identifier: 2006H0045
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Myopia

Keywords

Myopia; NeuroVision; Visual acuity; Contrast sensitivity

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

  Every 5th visit

• Contrast Sensitivity Function

  Every 5th visit

Secondary Outcomes (1)

• Refractive Error

  Every 10th visit

Study Arms (2)

A

EXPERIMENTAL

NeuroVision's NVC treatment for low myopia

Device: NeuroVision's NVC treatment for Low Myopia

B

NO INTERVENTION

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

Interventions

NeuroVision's NVC treatment for Low Myopia DEVICE

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.

A

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

College of Optometry, The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• 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.

  PMID: 8116270 BACKGROUND

• 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.

  PMID: 8506641 BACKGROUND

• 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.

  PMID: 8108388 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.

Results Point of Contact

• Title: Dr. Don Mutti
• Organization: The Ohio State University

mutti.2@osu.edu

614-247-7057

Study Officials

• Donald O Mutti, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-08

Locations

US (1)