Modified DIMS glasses for myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with myopia will be randomized to wear one of two modified DIMS lenses (D1 or D2) or standard single-vision lenses for daily use over 12 months. Weekly checks in the first month will monitor choroidal thickness and other eye measurements, followed by visits at 1, 6, and 12 months to track refraction and axial length. The study aims to see if the modified lenses can affect choroidal thickness and myopia progression differently than standard lenses. Cycloplegic refraction and axial length will be measured every six months. The investigation builds on prior DIMS-type optical approaches to myopia control in children and uses a randomized design to compare multiple lens types.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Hong Kong Chinese
* Age at enrolment: 6 - 13 years
* Myopia in spherical power: -1.00D to -5.00D in both eyes
* Astigmatism: equal or less than 2.00D
* The sum of spherical power and astigmatism: equal or less than -7.00D
* Anisometropia (spherical equivalent refraction (SER)): equal or less than 1.50D
* Previous myopia progression (valid documentation dated within 2 years before screening):

  * -0.50D (SER) per year or more in both eyes OR Axial length elongation: 0.27mm/year in both eyes
  * If myopia is initially detected during screening, eligibility requires myopia (in SER) below the 3rd percentile curve of refraction in both eyes.12
* Best corrected visual acuity: LogMAR 0.04 or better in both eyes
* Ocular health: no abnormalities in both internal and external ocular health
* Binocular vision: no strabismus and other binocular abnormalities
* Normal colour vision
* Willing to wear the study spectacles all the time (10 hours per day, for 7 days per week)

Exclusion Criteria:

* Previous or current treatment for myopia control (e.g., red-light therapy, atropine, orthokeratology, specialized spectacle lenses and contact lenses and oral supplements for myopic control)
* Existing or past eye diseases or surgeries (e.g., strabismus surgery, amblyopia, oculomotor nerve palsies, corneal disease, intraocular disease, etc.) that may have an impact on vision or visual development
* Long-term medication (intake at least 3 days/week) or medication/supplements that affect eye health
* Systemic diseases that may have an impact on vision or visual development (e.g., endocrine, cardiac and respiratory diseases, diabetes, Down syndrome, etc.)
* Allergic to cyclopentolate eye drops
* Individuals who, in the judgment of the Investigator, are unable to cooperate and follow instructions during eye examination.

Where it's running

• Optometry Research Clinic, School of Optometry, The Hong Kong Polytechnic University
  Kowloon, Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Rachel Ka Man Chun, PhD — School of Optometry, The Hong Kong Polytechnic University
• Study coordinator: Rachel Ka Man Chun, PhD
• Email: rachel.chun@polyu.edu.hk
• Phone: 852-27664224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.