Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00348218
Status:
COMPLETED
Last Update Posted:
2010-05-12
First Post:
2006-07-03
Brief Title:
Pilot Study of Neurovision to Improve Vision and Slow Myopia Progression in Children With Myopia
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
Pilot Study To Evaluate The Efficacy Of NeurovisionS NVC- Vision Correction Technology For The Improvement In Visual Acuity In Myopic Children And Slowing Down Of Myopia Progression
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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:
NeuroVisions NVC vision correction technology is a non-invasive patient-specific computerized treatment based on visual stimulation and facilitation of neural connections responsible for vision NeuroVisions 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 510k 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 technologys 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 subjects 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 QOVQOL 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 subjects 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 05DS 10DS or 15DS less than the subjects 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 subjects best refractive correction hisher 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 subjects 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 QOVQOL 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 QOVQOL 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 612 03 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 subjects binocular VA with the under-corrected eyewear is worse than 612 03 LogMAR for 2 consecutive follow-up visits new eyewear should be prescribed to allow at least 612 binocular VA
At Follow up Month 6 and 12 subjects will be requested to complete a QOVQOL Questionnaire 2 Annex F
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 510k 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 technologys 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 subjects 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 QOVQOL 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 subjects 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 05DS 10DS or 15DS less than the subjects 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 subjects best refractive correction hisher 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 subjects 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 QOVQOL 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 QOVQOL 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 612 03 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 subjects binocular VA with the under-corrected eyewear is worse than 612 03 LogMAR for 2 consecutive follow-up visits new eyewear should be prescribed to allow at least 612 binocular VA
At Follow up Month 6 and 12 subjects will be requested to complete a QOVQOL Questionnaire 2 Annex F
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None