A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
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|ClinicalTrials.gov Identifier: NCT00348075|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Neurovision||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|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|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348075
|Singapore Eye Research Institute|
|Singapore, Singapore, 168751|
|Principal Investigator:||Donald Tan, FRCS||Singapore Eye Research Institute|