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Sponsors and Collaborators: |
Singapore National Eye Centre Defence Medical Research Institute, Singapore Armed Forces Neurovision |
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Information provided by: | Singapore National Eye Centre |
ClinicalTrials.gov Identifier: | NCT00348075 |
To evaluate the efficacy of NeuroVision NVC vision correction technology to improve the vision of subjects with Low and Moderate Myopia in Asian eyes in Singapore
Condition | Intervention |
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Myopia |
Device: Neurovision |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Singapore Study To Evaluate The Efficacy OF Neurovision’S NVC™- Vision Correction Technology For The Visual Improvement In Subjects With Low Or Moderate Adult Myopia |
Study Start Date: | January 2004 |
NeuroVision has developed a novel vision correction technology, which is a scientifically based treatment to improve vision based on new principles of visual psychophysics. NeuroVision NVC Vision Correction Technology is a non-invasive, patient-specific treatment based on visual stimulation and facilitation of neural connections responsible for vision. The treatment involves a programmed series of interactive visual exercises in front of a computer, and does not involve any form of prescription medications, or surgical treatment.
The technology has been proven in both Israel and Singapore’s pilot study to work for myopia -1.50D and below.
This study is a clinical trial for Singapore Ministry of Defence personnel to evaluate the efficacy of this treatment beyond the proven myopia range. There will be 2 phases in the study; Phase 1 will include low myopes from -0.50D to -1.50D while Phase 2 covers moderate myopes from -1.75D to -3.00D. Subjects will be randomised into treatment and placebo group in the ratio of 3:1.
A randomized double masked controlled trial conducted in 2 Phases:
Phase I will involve 140 study subjects with low myopia randomized in a 3:1 randomization to receive NVC treatment versus placebo treatment.
It is assumed that the withdrawal rate will not exceed 20%, so that at least 112 study subjects will complete the treatment phase.
Interim analysis with stopping rule will be conducted after 3/4 of the patients complete the treatment phase.
Phase II will involve 180 study subjects with moderate myopia randomized in a 3:1 randomization to receive NVC treatment versus placebo treatment.
The 2 phases will be separate RCTs, with recruitment of Phase II subjects subsequent to completion of Phase I NVC treatments.
Ages Eligible for Study: | 17 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Phase I NVC-AM1 (Low Myopia):
The subject is able and willing to attend all study sessions and visits at the required frequency:
Inclusion criteria for Phase II NVC-AM2 (Moderate Myopia):
The subject is able and willing to attend all study sessions and visits at the required frequency:
Exclusion Criteria (for both Phase I and II):
Contact: Donald Tan, FRCS | snecdt@pacific.net.sg |
Singapore | |
Singapore Eye Research Institute | Recruiting |
Singapore, Singapore, 168751 | |
Principal Investigator: Donald Tan | |
Principal Investigator: Lionel Lee | |
Sub-Investigator: Mohamad Rosman | |
Sub-Investigator: Nir Ellenbogen | |
Sub-Investigator: Bill Chan | |
Sub-Investigator: Adeline Yang | |
Sub-Investigator: Mohamad Farook |
Principal Investigator: | Donald Tan, FRCS | Singapore Eye Research Institute |
Study ID Numbers: | R330/23/2003 |
Study First Received: | July 3, 2006 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00348075 |
Health Authority: | Singapore: Domain Specific Review Boards |
Neurovision Adult myopia Therapy |
Eye Diseases Myopia Refractive Errors |