Pilot Study of Neurovision to Improve Vision and Slow Myopia Progression in Children With Myopia

NCT00348218 | Completed Phase 1

• 1 other identifier: R462/11/2006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the effectiveness of Neurovision treatment in the improvement of vision in children being under-corrected and to assess the effectiveness of Neurovision treatment in slowing down myopia progression in children.

Conditions

Myopia

Keywords

Neurovision; Myopia Therapy

Outcome Measures

Primary Outcomes (7)

• Manifest Subjective and Objective refraction

• Accommodation amplitude, PRA and NRA

• Distance visual acuity (Monocular and binocular Under-corrected Visual Acuity, and Best Corrected Visual Acuity - BCVA)

• Cycloplegic Objective and Subjective refraction

• Distance cycloplegic under-corrected visual acuity.

• Contrast Sensitivity

• Ocular axial length measurements

Interventions

NeuroVision DEVICE

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The subject's age is between 7 to 9 years.
• The subject's cycloplegic refraction is at least -1.0DS in either eye.
• The subject's manifest spherical equivalence does not differ by more than 1.0 D from cycloplegic spherical equivalence
• The subject's visual acuity with an under correction of 1DS (compared to the manifest subjective VA), in both eyes, should not exceed 0.6 LogMAR.
• The subject's best corrected visual acuity 0.04 LogMAR (either eye)
• The subject is cognitively intact and is able to follow multiple step instructions.
• The subject and his parents/legal guardians are very keen to improve the habitual visual acuity and to reduce the progression rate of myopia
• 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 and no more than 40.
• 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.
• The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period (phase I).
• The subject's parent/legal guardian agrees to sign the Informed Consent Form (See Appendix D)
• Subject's parent/legal guardian agrees to follow the study instruction including use of optical aids

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 suffers from binocular vision problems, such as high exophoria / divergent squint / nystagmus
• 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
• NeuroVision: collaborator
• Health Promotion Board, Singapore: 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

• 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, 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

Related Links

• Singapore Eye Research Institute Website

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Donald Tan, FRCS

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

• Wei Han Chua, FRCS

  Singapore National Eye Centre

  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: June 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)