Trial Outcomes & Findings for Evaluating NeuroVision's Neural Vision Correction (NVC) Myopia Treatment (NCT NCT00469612)
NCT ID: NCT00469612
Last Updated: 2018-09-25
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Every 5th visit
Results posted on
2018-09-25
Participant Flow
Two subjects were recruited when study began, but before data were collected the study was terminated due to lack of resources.
Participant milestones
| Measure |
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.
|
No Intervention Group
The subjects in this group will serve as controls and will be the no intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
No Intervention Group
The subjects in this group will serve as controls and will be the no intervention group.
|
|---|---|---|
|
Overall Study
Study terminated before data collected
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NeuroVision's NVC Treatment for Low Myopia
n=2 Participants
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.
|
No Intervention Group
The subjects in this group will serve as controls and will be the no intervention group.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
0 Participants
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
—
|
2 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
—
|
0 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
—
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Every 5th visitPopulation: Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Every 5th visitPopulation: Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 10th visitPopulation: Two subjects were enrolled, but no data were collected because study was terminated due to lack of resources.
Outcome measures
Outcome data not reported
Adverse Events
NeuroVision's NVC Treatment for Low Myopia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place