A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348075
|Singapore Eye Research Institute|
|Singapore, Singapore, 168751|
|Principal Investigator:||Donald Tan, FRCS||Singapore Eye Research Institute|