Clinical trial NCT00348127: A Singapore Pilot Study to Assess Neurovision in Treatment of Low Myopia
Official title: A Singapore Pilot Study To Evaluate The Efficacy Of A Computerized System For The Vision Improvement Of People With Low Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: Neurovision
Myopia Therapy
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: Singapore Eye Research Institute
name: NeuroVision
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Manifest Subjective and Objective refraction
measure: Cycloplegic Objective refraction
measure: Accommodation amplitude
measure: Distance visual acuity (Uncorrected Visual Acuity - UCVA, and BCVA)
measure: Near visual acuity
measure: Contrast sensitivity (corrected and uncorrected)
measure: Visual Evoked Potential (VEP) and Multifocal VEP
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Donald Tan, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19.
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. doi: 10.1038/35372.
citation: 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.
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. doi: 10.1016/0042-6989(95)00281-2.
citation: Sagi D, Tanne D. Perceptual learning: learning to see. Curr Opin Neurobiol. 1994 Apr;4(2):195-9. doi: 10.1016/0959-4388(94)90072-8.
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. doi: 10.1073/pnas.91.4.1206.
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. doi: 10.1016/0042-6989(93)90081-7.
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. doi: 10.1073/pnas.93.13.6830.