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NCT07846787

Control of Myopia in Young Children Using H.O.P.E. Lenses Combined With 0.02% Atropine Eye Drops

Sponsor: Ruihua Wei

View on ClinicalTrials.gov

Summary

A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)

Official title: A Multicenter, Prospective, Intervention Study on the Control of Myopia in Young Children Using High-order Phase Element Array Microstructure Lenses (H.O.P.E.) in Combination With Low-concentration Atropine Eye Drops (0.02%)

Key Details

Gender

All

Age Range

6 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2026-09-30

Completion Date

2028-09-20

Last Updated

2026-09-29

Healthy Volunteers

Conditions

Myopia

Interventions

DEVICE

High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)

Wear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes.

DRUG

0.02% Atropine Sulfate Eye Drops

Wear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes.

Inclusion Criteria: 1. Age: 6-9 years old (6 years old but under 10 years old), gender not restricted; 2. Clinically diagnosed with bilateral myopia (after cycloplegia), refractive error within -6.00D \< SER ≤ -0.50D, astigmatism ≤ 1.50D, refractive anisometropia ≤ 1.50D (based on subjective refraction values); 3. Corrected visual acuity LogMAR ≤ 0.1; 4. Able to understand the research purpose, voluntarily participate, and the subject and his/her legal guardian sign the informed consent form. Exclusion Criteria: If a subject meets any of the following exclusion criteria, they will not be included in this study: 1. Those who have discontinued the use of atropine eye drops (due to glaucoma or a tendency towards glaucoma, or are allergic to scopolamine or the components of this product); 2. Those currently suffering from any of the following diseases that may affect vision or refractive errors, or ocular organic diseases: such as diseases causing damage to the lens like cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, acute/chronic keratitis, conjunctivitis, irregular cornea, keratoconus, manifest strabismus, fundus diseases, etc.; systemic diseases that may affect the eyes, such as immune system diseases, central nervous system diseases, Down syndrome, asthma, epilepsy, severe heart or lung function disorders, severe liver or kidney function impairments, etc.; 3. Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form; 4. Those who have used myopia control products within 90 days before signing the informed consent form (such as near-axial lenses, low-concentration atropine eye drops, corneal reshaping lenses, red light, etc.); 5. Those who cannot wear glasses regularly or use the medication as required (such as having a significant difference in compliance); 6. During the screening period, the intraocular pressure of either eye is greater than 21 mmHg or less than 10 mmHg, or the intraocular pressure difference between both eyes is ≥ 5 mmHg; 7. There is a severe abnormality in the accommodative function (accommodative amplitude \< 8D); 8. Only one eye meets the inclusion criteria; 9. Other situations that the researcher deems unsuitable for participating in this study.

Locations (1)

Tianjin Medical University Eye Hospital

Tianjin, China