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

• Sponsor: Ohio State University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00469612
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site Per Month: 0.1

Study Details

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:

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 or Disease	Intervention/Treatment	Phase
Myopia	Device: NeuroVision's NVC treatment for Low Myopia	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating the Efficacy of NeuroVisions's NVC Treatment for Low Myopia
• Actual Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: B The subjects in this group will serve as controls and will be the no intervention group.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Every 5th visit]

2. Contrast Sensitivity Function [Every 5th visit]

Secondary Outcome Measures

1. Refractive Error [Every 10th visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Polat U, Sagi D. The architecture of perceptual spatial interactions. Vision Res. 1994 Jan;34(1):73-8.

• Responsible Party: Donald Mutti, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT00469612
• Other Study ID Numbers: 2006H0045
• First Posted: May 4, 2007
• Last Update Posted: Sep 25, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Donald Mutti, Professor, Ohio State University: Myopia; NeuroVision; Visual acuity; Contrast sensitivity
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Two subjects were recruited when study began, but before data were collected the study was terminated due to lack of resources.

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia	No Intervention Group
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.	The subjects in this group will serve as controls and will be the no intervention group.
Period Title: Overall Study
STARTED	2	0
COMPLETED	0	0
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia	No Intervention Group	Total
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.	The subjects in this group will serve as controls and will be the no intervention group.	Total of all reporting groups
Overall Participants	2	0	2
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	2 100%	0 NaN	2 100%
>=65 years	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	2 100%	2 Infinity
Male	0 0%	0 NaN
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%	2 Infinity

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Time Frame	Every 5th visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia	No Intervention Group
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.	The subjects in this group will serve as controls and will be the no intervention group.
Measure Participants	0	0

2. Primary Outcome

Title	Contrast Sensitivity Function
Time Frame	Every 5th visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia	No Intervention Group
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.	The subjects in this group will serve as controls and will be the no intervention group.
Measure Participants	0	0

3. Secondary Outcome

Title	Refractive Error
Time Frame	Every 10th visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia	No Intervention Group
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.	The subjects in this group will serve as controls and will be the no intervention group.
Measure Participants	0	0

Adverse Events

Arm/Group Title	NeuroVision's NVC Treatment for Low Myopia		No Intervention Group
Arm/Group Description	NeuroVision's NVC treatment for low myopia 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.		The subjects in this group will serve as controls and will be the no intervention group.
All Cause Mortality
	NeuroVision's NVC Treatment for Low Myopia		No Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NeuroVision's NVC Treatment for Low Myopia		No Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	NeuroVision's NVC Treatment for Low Myopia		No Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.