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New treatment option for Myopia
Official title Clinical Investigation of a Novel Spectacle Lens on Slowing Down Juvenile Myopia Progression
ClinicalTrials.gov ID: NCT06850168
What this study is testing
- What it's testing
- The goal of this exploratory clinical trial is to evaluate the efficacy and safety of a test spectacle lens (standard single vision lens (SVL) during first year, and standard myopia control lens (MCL) in second year), designed with passive red-light emission, for the control of myopia progression in myopic children age 6 to 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Does the test spectacle lens designed with passive red-light emission provide significant myopia control effect to children?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- Be in good general health, based on his/her and parent's/guardian's knowledge.
You likely can't join if
- Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- Any binocular vision anomalies
- Amblyopia
- Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive...
- Participation in any clinical investigation within 30 days of the baseline visit.
See the full eligibility criteria
- Children equal to or greater than 6 years old and less than 11 years at the time of signing informed consent.
- Corrected spherical equivalent refraction (SER) between -0.75 D and -5.00 D with astigmatism not more than 2.50 D.
- Difference in SER (Anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected visual acuity better than or equal to +0.10 log MAR (20/25 or better with Snellen).
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Agree to wear spectacles for \>12 hours/day and at least 6 days/week.
- Willingness and ability to participate in investigation for 2 years and attend scheduled visits.
- Any ocular or systemic pathologies known to affect refractive status (e.g. keratoconus, diabetes, Down's syndrome etc.)
- Any binocular vision anomalies
- Amblyopia
- Use of prior myopia control treatment like specialized myopia control spectacles and contact lenses at least in the previous one month.
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- Participation in any clinical investigation within 30 days of the baseline visit.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.