Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00348218
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 12, 2010
Sponsor:
Collaborators:
NeuroVision
Health Promotion Board, Singapore
Information provided by:
Singapore National Eye Centre

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.

Condition or disease Intervention/treatment Phase
Myopia Device: NeuroVision Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Manifest Subjective and Objective refraction
  2. Accommodation amplitude, PRA and NRA
  3. Distance visual acuity (Monocular and binocular Under-corrected Visual Acuity, and Best Corrected Visual Acuity - BCVA)
  4. Cycloplegic Objective and Subjective refraction
  5. Distance cycloplegic under-corrected visual acuity.
  6. Contrast Sensitivity
  7. Ocular axial length measurements


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348218


Locations
Layout table for location information
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
NeuroVision
Health Promotion Board, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Donald Tan, FRCS Singapore Eye Research Institute
Principal Investigator: Wei Han Chua, FRCS Singapore National Eye Centre

Additional Information:
Publications:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00348218    
Other Study ID Numbers: R462/11/2006
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010
Keywords provided by Singapore National Eye Centre:
Neurovision
Myopia Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases