A Singapore Pilot Study to Assess Neurovision in Treatment of Low Myopia
|ClinicalTrials.gov Identifier: NCT00348127|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : June 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Neurovision||Phase 1|
The eye care industry has focused a majority of its resources on solving problems associated with the ocular or "front end" of the visual system. These investments have led to exciting technology advances, such as intraocular lenses (IOLs) and Laser Vision Correction (LVC) as well as in the development of contact lenses and improved eyewear.
NeuroVision's innovative Neural Vision Correction (NVC) technology has been developed through research focused solely on optimizing performance of the neural or "back end" of the visual system. NeuroVision's technology is distinguished from other products in this space by the Company's expert understanding of how the brain processes vision, its reliance on scientific and clinical research
It is the result of two decades of research by Dr. Uri Polat, founder, who has dedicated 20 years of scientific and clinical research to understanding how the brain processes visual information, how neural activity is related to visual perception, and how visual processing interacts with other neural systems. His work has been published in leading scientific journals and is widely cited by the scientific community.
NeuroVision's NVC vision correction technology is a non-invasive, patient-specific treatment based on visual stimulation and facilitation of neural connections responsible for vision.
The technology has been clinically proven in the treatment of adult amblyopia ("lazy eye"), which until now has been considered untreatable. The Company has received FDA 510(k) marketing clearance indicating NVC for the treatment of adult amblyopia in patients 9 years or older in the US. The Company also received Medical CE-Mark to market its Amblyopia and Low-Myopia products in the EU. Company products are also approved for use in Israel by the Israeli Ministry of Health - Device License Authority.
This study was a prospective non-controlled preliminary clinical study as a prelude to a randomized clinical trial, evaluating the efficacy and safety of NeuroVision NVC correction technology in improving visual acuity and contrast sensitivity function.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Singapore Pilot Study To Evaluate The Efficacy Of A Computerized System For The Vision Improvement Of People With Low Myopia|
|Study Start Date :||March 2003|
|Primary Completion Date :||October 2004|
|Study Completion Date :||October 2004|
- Manifest Subjective and Objective refraction
- Cycloplegic Objective refraction
- Accommodation amplitude
- Distance visual acuity (Uncorrected Visual Acuity - UCVA, and BCVA)
- Near visual acuity
- Contrast sensitivity (corrected and uncorrected)
- Visual Evoked Potential (VEP) and Multifocal VEP
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348127
|Singapore Eye Research Institute|
|Singapore, Singapore, 168751|
|Principal Investigator:||Donald Tan, FRCS||Singapore Eye Research Institute|