A Singapore Pilot Study to Assess Neurovision in Treatment of Low Myopia

Myopia Clinical Trial

Official title:

A Singapore Pilot Study To Evaluate The Efficacy Of A Computerized System For The Vision Improvement Of People With Low Myopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348127
• Other study ID #: R313/06/2003
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2006
• Last updated: June 23, 2010
• Start date: March 2003
• Est. completion date: October 2004

Study information

• Verified date: January 2010
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

To assess how well and safe is Neurovision technology in improving the vision of people with low myopia in Singapore

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

1. The subject's cycloplegic spherical equivalence in the worst eye does not exceed -1.5 DS and the astigmatism does not exceed 0.50 DC.

2. The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months.

3. The subject's age is between 17-55 years.

4. The subject's uncorrected visual acuity 0.7 LogMar

5. The subject's best corrected visual acuity 0.05 LogMar

6. The subject is cognitively intact and is able to follow multiple step instructions.

7. The subject is able and willing to attend all study sessions and visits at the required frequency:

1. The total number of treatments is individual, approximately 30.

2. The required pace for the treatment sessions is at least 3 sessions per week.

3. No foreseen interruptions longer than 2 weeks during the treatment course.

8. Subject (or subject's parent/legal guardian if subject is less than 21 years of age at study entry) agrees to sign the Informed Consent Form (See Appendix D)

Exclusion Criteria:

1. The subject suffers from any other eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism.

2. The subject suffers from myopia-related visual complications resulting in visual loss, including myopic macular degeneration, myopic cataract and previous or pre-existing myopic retinal detachment.

3. The subject is suffering from Diabetes Mellitus.

4. The subject has previously undergone a refractive surgery procedure in either eye.

5. The subject is or may be pregnant.

6. The subject has an activity limitation due to medical disorders (including migraines, seizure disorders, etc.), medications, or emotional status that might potentially impair the subject's ability to perform the treatment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Neurovision

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore National Eye Centre	NeuroVision, Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

Levi DM, Polat U, Hu YS. Improvement in Vernier acuity in adults with amblyopia. Practice makes better. Invest Ophthalmol Vis Sci. 1997 Jul;38(8):1493-510. Review. — View Citation

Levi DM, Polat U. Neural plasticity in adults with amblyopia. Proc Natl Acad Sci U S A. 1996 Jun 25;93(13):6830-4. — View Citation

Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. Epub 2004 Apr 19. — View Citation

Polat U, Mizobe K, Pettet MW, Kasamatsu T, Norcia AM. Collinear stimuli regulate visual responses depending on cell's contrast threshold. Nature. 1998 Feb 5;391(6667):580-4. — View Citation

Polat U, Norcia AM. Neurophysiological evidence for contrast dependent long-range facilitation and suppression in the human visual cortex. Vision Res. 1996 Jul;36(14):2099-109. — View Citation

Polat U, Sagi D. Lateral interactions between spatial channels: suppression and facilitation revealed by lateral masking experiments. Vision Res. 1993 May;33(7):993-9. — View Citation

Polat U, Sagi D. Spatial interactions in human vision: from near to far via experience-dependent cascades of connections. Proc Natl Acad Sci U S A. 1994 Feb 15;91(4):1206-9. — View Citation

Sagi D, Tanne D. Perceptual learning: learning to see. Curr Opin Neurobiol. 1994 Apr;4(2):195-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manifest Subjective and Objective refraction
Primary	Cycloplegic Objective refraction
Primary	Accommodation amplitude
Primary	Distance visual acuity (Uncorrected Visual Acuity - UCVA, and BCVA)
Primary	Near visual acuity
Primary	Contrast sensitivity (corrected and uncorrected)
Primary	Visual Evoked Potential (VEP) and Multifocal VEP

External Links

•   Neurovision Website
•   Singapore Eye Research Institute
•   Singapore National Eye Centre Website