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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Neurovision
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Neurovision, Adult myopia, Therapy

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Phase I NVC-AM1 (Low Myopia): 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 Inclusion criteria for Phase II NVC-AM2 (Moderate Myopia): The subject's cycloplegic spherical equivalence in the worst eye is within the range of -1.750DS to -3.0DS 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 the worst eye should not exceed 1.0 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) Exclusion Criteria (for both Phase I and II): 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.

Sites / Locations

  • Singapore Eye Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurovision

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2006
Last Updated
May 11, 2010
Sponsor
Singapore National Eye Centre
Collaborators
Defence Medical Research Institute, Singapore Armed Forces, NeuroVision
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1. Study Identification

Unique Protocol Identification Number
NCT00348075
Brief Title
A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
Official Title
A Singapore Study To Evaluate The Efficacy OF Neurovision'S NVC™- Vision Correction Technology For The Visual Improvement In Subjects With Low Or Moderate Adult Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Singapore National Eye Centre
Collaborators
Defence Medical Research Institute, Singapore Armed Forces, NeuroVision

4. Oversight

5. Study Description

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
Detailed Description
NeuroVision has developed a novel vision correction technology, which is a scientifically based treatment to improve vision based on new principles of visual psychophysics. NeuroVision NVC Vision Correction Technology is a non-invasive, patient-specific treatment based on visual stimulation and facilitation of neural connections responsible for vision. The treatment involves a programmed series of interactive visual exercises in front of a computer, and does not involve any form of prescription medications, or surgical treatment. The technology has been proven in both Israel and Singapore's pilot study to work for myopia -1.50D and below. This study is a clinical trial for Singapore Ministry of Defence personnel to evaluate the efficacy of this treatment beyond the proven myopia range. There will be 2 phases in the study; Phase 1 will include low myopes from -0.50D to -1.50D while Phase 2 covers moderate myopes from -1.75D to -3.00D. Subjects will be randomised into treatment and placebo group in the ratio of 3:1. A randomized double masked controlled trial conducted in 2 Phases: Phase I will involve 140 study subjects with low myopia randomized in a 3:1 randomization to receive NVC treatment versus placebo treatment. It is assumed that the withdrawal rate will not exceed 20%, so that at least 112 study subjects will complete the treatment phase. Interim analysis with stopping rule will be conducted after 3/4 of the patients complete the treatment phase. Phase II will involve 180 study subjects with moderate myopia randomized in a 3:1 randomization to receive NVC treatment versus placebo treatment. The 2 phases will be separate RCTs, with recruitment of Phase II subjects subsequent to completion of Phase I NVC treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Neurovision, Adult myopia, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Neurovision
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Neurovision

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Phase I NVC-AM1 (Low Myopia): 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 Inclusion criteria for Phase II NVC-AM2 (Moderate Myopia): The subject's cycloplegic spherical equivalence in the worst eye is within the range of -1.750DS to -3.0DS 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 the worst eye should not exceed 1.0 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) Exclusion Criteria (for both Phase I and II): 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Tan, FRCS
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
8506641
Citation
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.
Results Reference
background
PubMed Identifier
8038576
Citation
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.
Results Reference
background
PubMed Identifier
8776476
Citation
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.
Results Reference
background
PubMed Identifier
9468134
Citation
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.
Results Reference
background
PubMed Identifier
16629076
Citation
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.
Results Reference
background
PubMed Identifier
15096608
Citation
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.
Results Reference
background
Links:
URL
http://www.seri.com.sg/
Description
Singapore Eye Research Institute
URL
http://www.neuro-vision.com/
Description
Neurovision Website

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

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