What are we trying to learn?
The purpose of this research study is to demonstrate the safety and efficacy of a new spectacle lens design in reducing the rate of myopic progression in children. Your child, if selected, will be randomly assigned to one of three spectacle lens groups (two test groups and one control group).
About the study
If eligible, your child will be asked to wear the spectacles provided by us (frame chosen by you) and attend the following visit schedule over the course of three years. Please note, your child will receive a new pair of spectacle frames and study lenses for each year they participate in the study.
- Visit 0 – Screening visit to determine eligibility – 2.5 hours
- Visit 1 –Spectacle Dispense – 2 hours
- Visit 2– 1 month follow up – 1 hour
- Visit 3 – 6 month follow up – 1.5 hours
- Visit 4- 12 month follow up – 2.5 hours
- Visit 5- 18 month follow up – 1.5 hours
- Visit 6 – 24 month follow up – 2.5 hours
- Visit 7 – 30 month follow up – 1.5 hours
- Visit 8 – 36 month follow up and exit – 2.5 hours
- Take home questionnaire- completed every 2-weeks – 2.5 hours per year (completed by child/guardian)
* please note, additional unscheduled visits may be required if your child’s prescription changes throughout this study, and will be remunerated accordingly at the completion of this study
Total time commitment – Approx. 25 hours
The visits will include standard procedures that you might encounter when you attend an eye exam.
What are the requirements?
- Must be aged 6-10
- Current spectacle wearers with no contact lens experience
- Prescription range -0.75DS to -4.50DS, maximum astigmatism -1.25DC
In appreciation of your time, you will receive up to $690 ($360 for your child and $330 for parent/guardian) that will be prorated over a three-year period. The following materials will also be provided:
- Your child will have an opportunity to select a new pair of spectacle frames for each year of participation in the study (i.e. up to 3 frames over 3 years) from a selection of frames provided by CORE
- At study completion, your child will also receive a final pair of spectacles, including single-vision lenses and their choice of frames (from a selection).