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Status:

COMPLETED

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

Lead Sponsor:

Singapore National Eye Centre

Collaborating Sponsors:

Defence Medical Research Institute, Singapore Armed Forces

NeuroVision

Conditions:

Myopia

Eligibility:

All Genders

17-55 years

Phase:

NA

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 Corr...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    January 1 2009

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00348075

    Start Date

    January 1 2004

    End Date

    January 1 2009

    Last Update

    May 12 2010

    Active Locations (1)

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    Singapore Eye Research Institute

    Singapore, Singapore, 168751