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Status:

COMPLETED

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

Lead Sponsor:

Singapore National Eye Centre

Collaborating Sponsors:

NeuroVision

Health Promotion Board, Singapore

Conditions:

Myopia

Eligibility:

All Genders

7-9 years

Phase:

PHASE1

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 sl...

Detailed Description

NeuroVision's NVC vision correction technology is a non-invasive, patient-specific computerized treatment based on visual stimulation and facilitation of neural connections responsible for vision. Neu...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2009

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00348218

Start Date

June 1 2006

End Date

April 1 2009

Last Update

May 12 2010

Active Locations (1)

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1

Singapore Eye Research Institute

Singapore, Singapore, 168751