A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
|Singapore Eye Research Institute|
|Singapore, Singapore, 168751|
|Principal Investigator:||Donald Tan, FRCS||Singapore Eye Research Institute|