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

This study has been completed.
Sponsor:
Collaborators:
NeuroVision
Health Promotion Board, Singapore
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00348218
First received: July 3, 2006
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Myopia
Device: NeuroVision
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study To Evaluate The Efficacy Of Neurovision'S NVC™- Vision Correction Technology For The Improvement In Visual Acuity In Myopic Children And Slowing Down Of Myopia Progression

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: June 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject's age is between 7 to 9 years.
  2. The subject's cycloplegic refraction is at least -1.0DS in either eye.
  3. The subject's manifest spherical equivalence does not differ by more than 1.0 D from cycloplegic spherical equivalence
  4. 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.
  5. The subject's best corrected visual acuity 0.04 LogMAR (either eye)
  6. The subject is cognitively intact and is able to follow multiple step instructions.
  7. The subject and his parents/legal guardians are very keen to improve the habitual visual acuity and to reduce the progression rate of myopia
  8. 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.
  9. The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period (phase I).
  10. The subject's parent/legal guardian agrees to sign the Informed Consent Form (See Appendix D)
  11. Subject's parent/legal guardian agrees to follow the study instruction including use of optical aids

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 suffers from binocular vision problems, such as high exophoria / divergent squint / nystagmus
  5. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348218

Locations
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
NeuroVision
Health Promotion Board, Singapore
Investigators
Principal Investigator: Donald Tan, FRCS Singapore Eye Research Institute
Principal Investigator: Wei Han Chua, FRCS Singapore National Eye Centre
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00348218     History of Changes
Other Study ID Numbers: R462/11/2006
Study First Received: July 3, 2006
Last Updated: May 10, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore National Eye Centre:
Neurovision
Myopia Therapy

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014