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MyopiaNCT00348075

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

A study testing Neurovision in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 17 to 55 years
Conditions the study is for
Myopia
What is being tested?
Neurovision
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
1 siteSingapore
Study dates
Jan 2004to Jan 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 27Show fewer
  • 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
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore Eye Research Institute

    Singapore, 168751

Other trials in Singapore

About this study

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

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

Read the 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.

Conditions
Myopia
Being tested
Neurovision
Keywords
Neurovision, Adult myopia, Therapy
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurovisionDevice

Study groups in NCT00348075
Study groupRoleWhat they receive
NeurovisionExperimentalNot described
Receives: Device: Neurovision

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348075
Sponsor's protocol ID
R330/23/2003
Status last verified
May 2010
First submitted
3 Jul 2006
Last updated
12 May 2010
Results posted
No

Publications

  • 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.

    PubMed 8506641

  • 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.

    PubMed 8038576

  • 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.

    PubMed 8776476

  • 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.

    PubMed 9468134

  • 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.

    PubMed 16629076

  • 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.

    PubMed 15096608

Questions about this trial

What is this clinical trial studying?

A study testing Neurovision in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00348075, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.

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