Recruiting NCT07566234

Evaluation of Contact Lenses and Myopia.

No phase Interventional Pre-myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Test Lens - Dual Focus.
Who it may be relevant to: Registry conditions: Pre-myopia. Basic parameters: 8 years — 10 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Myopia Prevention Study in Chinese Population With Dual Focus Myopia Control Lenses.

This study will evaluate the effect of dual focus contact lenses on Myopia prevention.

Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years. [Time frame: Through study completion, 2 years.]

Male and female children aged between 8-10 years inclusive.
Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
Astigmatism ≤ -1.00D in both eyes.
Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms.
Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
Be in good general health, based on his/her and parent's/guardian's knowledge.
Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.

History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
Ocular or systemic disease that contraindicates contact lens wear.
Active allergic conjunctivitis.
Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
Keratoconus or an irregular cornea.
History of clinically significant binocular vision abnormality or strabismus.
Any active anterior segment finding that would contraindicate contact lens wear.
The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07566234 · CV-25-01