A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia

NCT00348075 | Completed

• 1 other identifier: R330/23/2003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of NeuroVision NVC vision correction technology to improve the vision of subjects with Low and Moderate Myopia in Asian eyes in Singapore

Conditions

Myopia

Keywords

Neurovision; Adult myopia; Therapy

Study Arms (1)

Neurovision

EXPERIMENTAL

Device: Neurovision

Interventions

Neurovision DEVICE

Neurovision

Eligibility Criteria

• Age: 17 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 is within the range of -0.50DS to -1.50DS of myopia, and astigmatism does not exceed 0.75DC in either eye.
• 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 in both eyes should be between 0.1 and 0.7 logMAR.
• The subject's best corrected visual acuity 0.05 LogMar (either eye)
• The subject is cognitively intact and is able to follow multiple step instructions.
• The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period. The subject is able to cease contact lens wear for at least a week before attending the Baseline examination, Post-treatment evaluation and Persistence evaluation.
• 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)
• Manifest spherical equivalence - not more than 1.0Ds difference from cycloplegic spherical equivalence
• Unaided VA difference between both eyes is less than 0.3 logMAR
• The patient is very keen to improve unaided vision and to decrease the dependency on eye glasses

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
• Defence Medical Research Institute, Singapore Armed Forces: collaborator
• NeuroVision: collaborator

Study Sites (1)

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Related Publications (6)

• 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

• 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, 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

• 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

• Lim KL, Fam HB. NeuroVision treatment for low myopia following LASIK regression. J Refract Surg. 2006 Apr;22(4):406-8. doi: 10.3928/1081-597X-20060401-20.

  PMID: 16629076 BACKGROUND

• 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

Related Links

• Singapore Eye Research Institute
• Neurovision 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: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 4, 2006
• Study Start: January 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)