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

NCT00348127 | Completed Phase 1

• 1 other identifier: R313/06/2003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Keywords

Neurovision; Myopia Therapy

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

Neurovision DEVICE

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• The subject's refractive status is stable, with no increase beyond 0.5D in sphere or cylinder over the last six months.
• The subject's age is between 17-55 years.
• The subject's uncorrected visual acuity 0.7 LogMar
• The subject's best corrected visual acuity 0.05 LogMar
• The subject is cognitively intact and is able to follow multiple step instructions.
• The subject is able and willing to attend all study sessions and visits at the required frequency:
• The total number of treatments is individual, approximately 30.
• The required pace for the treatment sessions is at least 3 sessions per week.
• No foreseen interruptions longer than 2 weeks during the treatment course.
• 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)

You may not qualify if:

• The subject suffers from any other eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism.
• 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.
• The subject is suffering from Diabetes Mellitus.
• The subject has previously undergone a refractive surgery procedure in either eye.
• The subject is or may be pregnant.
• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Singapore Eye Research Institute: collaborator
• NeuroVision: collaborator

Study Sites (1)

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Related Publications (8)

• 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.

  PMID: 15096608 BACKGROUND

• 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.

  PMID: 9468134 BACKGROUND

• 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.

  PMID: 9224277 BACKGROUND

• 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.

  PMID: 8776476 BACKGROUND

• 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.

  PMID: 8038576 BACKGROUND

• 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.

  PMID: 8108388 BACKGROUND

• 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.

  PMID: 8506641 BACKGROUND

• 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.

  PMID: 8692904 BACKGROUND

Related Links

• Singapore Eye Research Institute
• Singapore National Eye Centre Website

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Donald Tan, FRCS

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 4, 2006
• Study Start: March 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: June 24, 2010

Record last verified: 2010-01

Locations

SG (1)