A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
- Conditions
- Myopia
- Interventions
- Device: Neurovision
- Registration Number
- NCT00348075
- Lead Sponsor
- Singapore National Eye Centre
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Neurovision Neurovision -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Singapore Eye Research Institute
🇸🇬Singapore, Singapore