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MyopiaPhase 1NCT00348127

A Singapore Pilot Study to Assess Neurovision in Treatment of Low Myopia

A Phase 1 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 assess how well and safe is Neurovision technology in improving the vision of people with low myopia in Singapore Read more about this study

Who is it for?
Ages 15 to 55 years
Conditions the study is for
Myopia
What is being tested?
Neurovision
Type of treatment
Medical device
How many people
Not given
Where
1 siteSingapore
Study dates
Mar 2003to Oct 2004
Phase
Phase 1
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 15 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 does not exceed -1.5 DS and the astigmatism does not exceed 0.50 DC.
  • 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 0.7 LogMar
  • The subject's best corrected visual acuity 0.05 LogMar
  • The subject is cognitively intact and is able to follow multiple step instructions.
Show all 11Show fewer
  • 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 Pilot Study To Evaluate The Efficacy Of A Computerized System For The Vision Improvement Of People With Low Myopia

To assess how well and safe is Neurovision technology in improving the vision of people with low myopia in Singapore

Read the detailed description

The eye care industry has focused a majority of its resources on solving problems associated with the ocular or "front end" of the visual system. These investments have led to exciting technology advances, such as intraocular lenses (IOLs) and Laser Vision Correction (LVC) as well as in the development of contact lenses and improved eyewear.

NeuroVision's innovative Neural Vision Correction (NVC) technology has been developed through research focused solely on optimizing performance of the neural or "back end" of the visual system. NeuroVision's technology is distinguished from other products in this space by the Company's expert understanding of how the brain processes vision, its reliance on scientific and clinical research

It is the result of two decades of research by Dr. Uri Polat, founder, who has dedicated 20 years of scientific and clinical research to understanding how the brain processes visual information, how neural activity is related to visual perception, and how visual processing interacts with other neural systems. His work has been published in leading scientific journals and is widely cited by the scientific community.

NeuroVision's NVC vision correction technology is a non-invasive, patient-specific treatment based on visual stimulation and facilitation of neural connections responsible for vision.

The technology has been clinically proven in the treatment of adult amblyopia ("lazy eye"), which until now has been considered untreatable. The Company has received FDA 510(k) marketing clearance indicating NVC for the treatment of adult amblyopia in patients 9 years or older in the US. The Company also received Medical CE-Mark to market its Amblyopia and Low-Myopia products in the EU. Company products are also approved for use in Israel by the Israeli Ministry of Health - Device License Authority.

This study was a prospective non-controlled preliminary clinical study as a prelude to a randomized clinical trial, evaluating the efficacy and safety of NeuroVision NVC correction technology in improving visual acuity and contrast sensitivity function.

Conditions
Myopia
Being tested
Neurovision
Keywords
Neurovision, 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manifest Subjective and Objective refraction

  2. Cycloplegic Objective refraction

  3. Accommodation amplitude

  4. Distance visual acuity (Uncorrected Visual Acuity - UCVA, and BCVA)

  5. Near visual acuity

  6. Contrast sensitivity (corrected and uncorrected)

  7. Visual Evoked Potential (VEP) and Multifocal VEP

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 startMar 2003
  3. Primary completionOct 2004
  4. Study completionOct 2004

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348127
Sponsor's protocol ID
R313/06/2003
Status last verified
Jan 2010
First submitted
3 Jul 2006
Last updated
24 Jun 2010
Results posted
No

Publications

  • 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

  • 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

  • Levi DM, Polat U, Hu YS. Improvement in Vernier acuity in adults with amblyopia. Practice makes better. Invest Ophthalmol Vis Sci. 1997 Jul;38(8):1493-510.

    PubMed 9224277

  • 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

  • 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, Sagi D. Spatial interactions in human vision: from near to far via experience-dependent cascades of connections. Proc Natl Acad Sci U S A. 1994 Feb 15;91(4):1206-9. doi: 10.1073/pnas.91.4.1206.

    PubMed 8108388

  • 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

  • Levi DM, Polat U. Neural plasticity in adults with amblyopia. Proc Natl Acad Sci U S A. 1996 Jun 25;93(13):6830-4. doi: 10.1073/pnas.93.13.6830.

    PubMed 8692904

Questions about this trial

What is this clinical trial studying?

A Phase 1 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 11 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 24 Jun 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Manifest Subjective and Objective refraction. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00348127, which also lists 8 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 24 Jun 2010.

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