Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT07264361
Eligibility Criteria:
Inclusion Criteria:
* Age between 6 and 14 years;
* Cycloplegic spherical equivalent refraction between -1.50 D and -5.00 D with astigmatism ≥ -1.50 D in both eyes;
* Absolute interocular difference in spherical equivalent refraction ≤ 1.50 D;
* Binocular best-corrected visual acuity ≥ 1.0;
* Intraocular pressure between 10 and 21 mmHg in both eyes;
* Volunteer to participate in this clinical trial with signature of the informed consent form.
Exclusion Criteria:
* History of eye injury or intraocular surgery or ocular trauma;
* Clinically abnormal slit-lamp findings;
* Abnormal fundus examination;
* Presence of ocular diseases such as cataract, glaucoma, fundus pathology, ocular trauma, manifest strabismus, or any other condition affecting visual function;
* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
* Participation in a drug clinical trial within 3 months or a device clinical trial within 1 month prior to enrollment;
* Participation in any myopia control clinical trial within the past 3 months and a history of myopia control interventions (e.g., orthokeratology, atropine);
* Only one eye meeting the inclusion criteria;
* Inability to attend regular ophthalmic examinations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT07264361
Study Brief:
Protocol Section:
NCT07264361