Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05477329 |
| Other study ID # |
MCIS2021 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
July 2022 |
| Source |
Shamir Optical Industry Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this trial is evaluating the clinical effect of a myopia control spectacle
lens compared to a single vision spectacle lens in slowing down the progression of myopia in
children living in Israel.
Description:
TRIAL PLAN
Screening visit (VISIT 1)
- Enrollment criteria verification
- Signing informed consent
- Baseline documentation of medical history, parental and siblings myopia, indoor and
outdoor activities profile and socioeconomic profile
- Lensmeter measurements of participants spectacles
- Performing baseline measurements including best corrected VA, objective & subjective
refraction under cycloplegia, PR under cycloplegia*, slit lamp examination, functional
tests: cover test, titmus test, worth four dot test, axial length** and pupil size
measurements
- Frame selection and frame measurements
- Lens order completion and sending to manufacturing
Randomization Procedures (following VISIT 1) Randomization procedures should be performed by
the trial coordinator following visit 1. The participant will then be allocated to the test
or control group.
Manufacturing Procedures (following VISIT 1) The manufacturing technician will take care of
the manufacturing processes according to the lens type (test or control) and the mounting on
the frame. The test spectacles will then be sent to the site for delivery.
Delivery visit (VISIT 2) performed ~10 days after screening visit
- Trial spectacles delivery
- Subjective questionnaire while wearing the trial spectacles
- Best corrected far and near VA (with the trial spectacles)
- Confrontation visual field test with the trial spectacles
- Giving instructions about wearing the trial spectacles
- Documenting adverse events if relevant
Follow-up visit performed 6 months (±1 week) after the previous visit (VISITS 3,4,5,6)
- Documentation of any change medical history since last visit
- Subjective questionnaire regarding the wearing period with the trial spectacles
(feedback performing follow-up measurements including best corrected far and near VA,
objective & subjective refraction under cycloplegia, PR under cycloplegia*, slit lamp
examination, functional tests: cover test, titmus test, worth four dot test, axial
length and pupil size measurements
- If the subjective refraction will find a SE (Sphere Equivalent) change from last
refraction of at least -0.50D, a new lens order should be made for new lenses, and a
delivery visit should be set in order to deliver the new test spectacles. The procedures
mentioned above in the delivery visit (visit 2) should then be performed.
- Documenting adverse events if relevant
Additional unscheduled visits
- May be scheduled as needed if special needs occur
- Procedures will be defined by the investigator
- Documenting adverse events if relevant
Total duration of trial per patient: 24 months.
ETHICAL ISSUES
This trial will be conducted according to the applicable local regulations and the GCP. All
essential documents will be reviewed and approved by the ethics committee prior to the
beginning of the trial. Any amendments of these documents will be reviewed and approved by
the ethics committee prior to implantation in the trial.
Informed Consent The investigator will give the participant and their parent/legal guardian a
full explanation about the trial and will answer all their question regarding participating
in the trial.
The investigator will explain that the participant will be able to withdraw from the trial at
any stage for any reason.
The participants parent/legal guardian will sign the informed consent form and will receive a
signed copy of it.
Data confidentiality All identification details about the participants in the trial will be
held by the investigator in a secured log file kept at the trial site.
Access to the identification details will not be allowed to any unauthorized party and will
not be disclosed in any report/document relating to the trial.
Terminating the participation in the trial
These are the cases in which an early termination of the participation in the trial may
occur:
1. Should the myopia progression of the participant will be more than 1.00 D after 1 year
or other significant refractive changes (such as more than 0.5[D] cylinder) - the
investigator will recommend the participant to discontinue the participation in the
trial and to consider using other myopia control treatments such as low dose Atropine
drops.
2. Should the far/near VA with the trial spectacles will be less than the best corrected VA
of the participant, the investigator will consider recommending the participant to
discontinue the participation in the trial.
RISK EVALUATION/ ADVERSE EVENTS
The optical design of the test lens, with the gradual positive peripheral power, induce a
certain amount of aberrations in the peripheral areas of the lens. These aberrations were
designed such that a good level of compliance will be achieved so that the participant will
be able to wear the lens.
Adverse events are unlikely to occur, yet it should be mentioned that a participant should
not wear this lens in case of one/more of the following exist:
- Feeling significant amount of discomfort while wearing the lens such that the safety of
the participant might be at risk.
- Vestibular disorders The participants in the trial will be free to contact the
investigator at any time during the wearing period in order to report any unexpected
events that might occur. The investigator will decide based on the report whether the
child should be excluded from continuing the trial.
Furthermore, it should be noted that a parallel clinical trial is being conducted these days
in AIER hospital in China, managed and supervised by Brien Holden Vision Institution
(Australia). The trial is similar to our trial, with the same trial product, on a group of
140 participants with the same enrollment criteria, including similar trial procedures and
trial plan. The trial started at November 2020, and as for now most of the participants has
worn the test spectacles for a few months with no adverse events reported.
DATA MANAGEMENT
Database An electronic data base will be held and maintained, into which all the source data
will be electronically transferred from the measuring devices, or if not possible, will be
typed in and source data (printouts or location of data) will be kept in the participants
file. At any case, all source data (printouts or location of data) should be kept in the
participants file.
The electronic data base will be backed up on a daily basis
Access to data:
The investigator will be able to allow access to data to the Sponsor (without identification
data) as per request.
The investigator will be able to allow access to data to the Monitoring staff according to
the monitoring plan that will be defined.
