Active — Not RecruitingNot Applicable

Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes

Hong Kong118 participantsStarted 2023-07-29

Plain-language summary

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * SER: -0.75D or below in both eyes * Documented history of fast progressing myopia, either in SER or AL * SER progression: 0.50D/year or more * AL elongation: 0.27mm/year or more * For children aged 4-6 years without past prescription forms, * 4-5 years old: myopia of -0.75D or below in both eyes * 6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below * Best-corrected visual acuity (VA) in both eyes: * 4 - 6 years old: 0.20 logMAR (or its equivalent) or better * 7-12 years old: 0.00 logMAR (or its equivalent) or better * Acceptance of random group allocation and the masked study design * Anisometropia of 1.50 D or less * Astigmatism of 2.00 D or less Exclusion Criteria: * Strabismus and binocular vision abnormalities * Ocular and systemic abnormalities * Prior experience of myopia control

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cycloplegic refraction change in spherical equivalent refraction (SER)

Timeframe: Baseline, every 6 months for 4 years

Trial details

NCT IDNCT05888792

SponsorThe Hong Kong Polytechnic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Myopia trials

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.