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Study was stopped due to lack of resources on part of investigators.
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Every 5th visit | |
| Contrast Sensitivity Function | Every 5th visit |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive Error | Every 10th visit |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald O Mutti, OD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Optometry, The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8116270 | Background | 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. | |
| 8506641 | 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. |
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Two subjects were recruited when study began, but before data were collected the study was terminated due to lack of resources.
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| ID | Title | Description |
|---|---|---|
| FG000 | NeuroVision's NVC Treatment for Low Myopia | 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. |
| FG001 | No Intervention Group | The subjects in this group will serve as controls and will be the no intervention group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.
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| ID | Title | Description |
|---|---|---|
| BG000 | NeuroVision's NVC Treatment for Low Myopia | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources. | Posted | Every 5th visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NeuroVision's NVC Treatment for Low Myopia | 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. |
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Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Don Mutti | The Ohio State University | 614-247-7057 | mutti.2@osu.edu |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| 8108388 | 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. |
| BG001 | No Intervention Group | The subjects in this group will serve as controls and will be the no intervention group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | No Intervention Group | The subjects in this group will serve as controls and will be the no intervention group. |
|
| Primary | Contrast Sensitivity Function | Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources. | Posted | Every 5th visit |
|
|
| Secondary | Refractive Error | Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources. | Posted | Every 10th visit |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | No Intervention Group | The subjects in this group will serve as controls and will be the no intervention group. | 0 | 0 | 0 | 0 |
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