Pilot Study of Neurovision to Improve Vision and Slow Myopia Progression in Children With Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      NeuroVision's NVC vision correction technology is a non-invasive, patient-specific
      computerized treatment based on visual stimulation and facilitation of neural connections
      responsible for vision. NeuroVision's Neural Vision Correction TM (NVC) technology has been
      developed through research focused solely on optimizing performance of the neural or "back
      end" of the visual system, and is based on two decades of visual neuroscience research by the
      founder, Dr Uri Polat, whose work, which has been published in leading scientific journals,
      relates 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.

      The technology has been clinically proven in the treatment of adult amblyopia, which until
      now has been considered untreatable, with a RCT in which follow-up of up to 2 years shows
      good retention of visual improvement. 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 a Medical CE-Mark to market its Amblyopia and Low-Myopia products
      in the European Union. Company products are also approved for use in Israel by the Israeli
      Ministry of Health - Device License Authority. Additional proof-of-concept studies have been
      performed in Israel and Singapore indicating the technology's potential to improve vision of
      subjects having low myopia.

      Today, NeuroVision commercially offers the Low Myopia treatment in Singapore. Initial results
      of the commercial treatment are even better than the proof-of-concept studies, emphasizing
      the importance of patient motivation and compliance in this treatment.

      Based on the promising results of the Low Myopia treatment in adults, this study intends to
      evaluate the efficacy of NVC treatment in myopic children, by improving their quality of
      vision and reducing the progress rate of their Myopia.

      The first objective of this study is to evaluate the improvement of visual acuity in children
      being under-corrected. As the myopia increases rapidly in many children, their habitual
      eyewear cannot match their exact degree of myopia on a day by day basis. As a result, many
      children suffer from reduced quality of vision (as shown also in data from the Singapore
      Cohort Study of the Risk Factors of Myopia [SCORM] study). Therefore, the first goal of this
      study is to evaluate the effectiveness of NeuroVision treatment in the improvement of the
      under-corrected visual acuity of these children.

      The second objective is to evaluate the effectiveness of NeuroVision treatment in the
      reduction of the myopia progression rate in children. As detailed later on in this document,
      studies on animals showed that under-correcting myopia can reduce its progression rate (or
      even result in emmetropization). Therefore, the second goal of this study is to evaluate the
      possibility of significantly under-correcting myopia in children that had undergone
      NeuroVision treatment, and check how it affects the progression of their myopia.

      To achieve the above objectives, a large scale (few hundred subjects) clinical study on
      school children, is required. This pilot study is designed to examine the feasibility of such
      a large scale study, from clinical, administrative and logistic points of view.

      Treatment flow and process

      The treatment flow is composed of the following phases

        1. Screening and Enrollment

           The Screening Evaluation phase includes the following steps:

             1. Demographic details

             2. General medical history

             3. Baseline Examination I. Manifest Subjective and Objective refraction II.
                Accommodation amplitude, PRA and NRA III. Distance visual acuity (Monocular and
                binocular Under-corrected Visual Acuity, and Best Corrected Visual Acuity - BCVA)
                IV. Cycloplegic Objective and Subjective refraction V. Distance cycloplegic
                under-corrected visual acuity. VI. Ocular axial length measurements

           For detailed description of the above examinations, refer to Appendices A-B.

           After the completion of all the required examinations, subject's data will be reviewed
           and study investigators make a final enrolment decision.

           Before starting the computerized evaluations, subjects will undergo an additional
           Distance Visual Acuity and Contrast Sensitivity examinations at the school.

           The results of these additional examinations will be used as a baseline reference for
           the periodic examinations that will be done during the treatment period.

           Enrolled Subjects will be requested to complete a QOV/QOL Questionnaire 1 (Annex E)
           before the treatment starts

        2. NVC Computerized Evaluation

           The Computerized Evaluation sessions are conducted in order to allow the NVC system to
           identify the visual abilities and inefficiencies and to thereby define individual
           parameters that will affect the subject's treatment plan.

           This phase is comprised of two (2) to three (3) sessions.

           Training Glasses:

           NeuroVision will determine the power of the training eyeglasses the subject will need
           for the NVC treatment start. The possible training glasses are 0.5DS, 1.0DS or 1.5DS
           less than the subject's full prescription. In some cases, there will be no training
           glasses.

           In some cases a subject might be instructed to train one eye only for a part of the
           treatment sessions. The other eye will be then covered by a semi-translucent lens.

           The decisions are made by NeuroVision based on the subject's best refractive correction,
           his/her under-corrected VA and the computerized evaluation, and will be reported to the
           study coordinator.

        3. NVC Treatment

           The total number of sessions to complete the treatment course is not defined in advance.
           It is determined by the NVC system during the course of treatment according to each
           subject's visual abilities and performance. Typically patient should undergo 30 sessions
           during this phase.

           The subject should perform on average three (3) sessions per week.

           During this phase no visit interruptions longer than two (2) weeks on aggregate are
           permitted.

           Periodic visual acuity and contrast sensitivity examinations should be performed after
           every 5 treatment sessions in the school

           As progress is made, the training glasses previously provided to the subject may be
           replaced by other training glasses with less power, or entirely removed. The clinician
           and the subject will be informed about the training glass replacement in advance.

           After completing 15 treatment sessions (mid-term), subjects will be requested to
           complete a QOV/QOL Questionnaire 2 (Annex F) before commencing Treatment Session 16.

           NOTE:

           WHEN VA TEST AND THE TREATMENT SESSION ARE TO BE PERFORMED AT THE SAME VISIT, PERIODIC
           VA TESTS SHOULD BE ALWAYS CONDUCTED BEFORE THE PERFORMANCE OF A TREATMENT SESSION!

        4. End of Treatment Decision

           Subject will terminate the treatment sequence according to the end of treatment criteria
           (see summary of study design)

           Following the end of Treatment decision, the subject should be scheduled for Post
           Treatment Examinations (PTE) within 2 weeks.

           For follow up visits, visit range allowed is within +/- two weeks of the expected dates

        5. Post Treatment Examination (PTE)

           The Post Treatment Examination at SERI will include visual acuity tests, amplitude of
           accommodation, relative accommodation, cover test, cycloplegic refraction and distance
           under-corrected visual acuity and axial length measurement.

           Subjects will be requested to complete a QOV/QOL Questionnaire 2 (Annex F)

        6. Prescription of under-corrected eyewear

           After the end of the treatment, subjects should be prescribed with under-corrected
           eyewear.

           The under-corrected eyewear should be the lowest possible refractive correction in which
           that subject has at least 6/12 (0.3 LogMAR) binocular VA.

           The subject should be instructed to use the new eyewear instead of the current one (if
           any) for at least the 12 months monitoring period.

        7. Follow-Up Examinations at Months 3, 6, 9 and 12

      Follow-Up Examinations at Months 3, 6, 9 and 12 post treatment at SERI will include visual
      acuity tests, amplitude of accommodation, relative accommodation, cover test, cycloplegic
      refraction and distance under-corrected visual acuity.

      In case that the subject's binocular VA with the under-corrected eyewear is worse than 6/12
      (0.3 LogMAR) for 2 consecutive follow-up visits, new eyewear should be prescribed to allow at
      least 6/12 binocular VA.

      At Follow up Month 6 and 12, subjects will be requested to complete a QOV/QOL Questionnaire 2
      (Annex F)."
    

Intervention name(s): NeuroVision
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurovision; Myopia Therapy