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

NCT07846787 | Not Yet Recruiting

• 1 other identifier: KCAK260A2026001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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%)

Conditions

Myopia

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

• The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

• The change in AL (axial length) from the baseline after wearing the glasses for 12 months

  From enrollment to the end of treatment at 12 months

Study Arms (3)

Group A (H.O.P.E. Lens Group)

ACTIVE COMPARATOR

Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.)

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

Group B (0.02% Atropine group)

ACTIVE COMPARATOR

Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)

Drug: 0.02% Atropine Sulfate Eye Drops

Group C (H.O.P.E. lenses + 0.02% atropine group)

EXPERIMENTAL

Wearing H.O.P.E. lens frame glasses (provided by Shenyang Kangnd Medical Technology Co., Ltd.); Use 0.02% atropine sulfate eye drops (provided by Shenyang Xingqi Eye Pharmaceuticals Co., Ltd.)

Device: High-order Phase Element Array Microstructure Design Lens (H.O.P.E.); Drug: 0.02% Atropine Sulfate Eye Drops

Interventions

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

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

Group A (H.O.P.E. Lens Group); Group C (H.O.P.E. lenses + 0.02% atropine group)

0.02% Atropine Sulfate Eye Drops DRUG

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

Group B (0.02% Atropine group); Group C (H.O.P.E. lenses + 0.02% atropine group)

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6-9 years old (6 years old but under 10 years old), gender not restricted;
• 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);
• Corrected visual acuity LogMAR ≤ 0.1;
• Able to understand the research purpose, voluntarily participate, and the subject and his/her legal guardian sign the informed consent form.

You may not qualify if:

• 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);
• 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.;
• Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form;
• 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.);
• Those who cannot wear glasses regularly or use the medication as required (such as having a significant difference in compliance);
• 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;
• There is a severe abnormality in the accommodative function (accommodative amplitude \< 8D);
• Other situations that the researcher deems unsuitable for participating in this study.

Sponsors & Collaborators

• Ruihua Wei: lead
• Tianjin Medical University Eye Hospital: collaborator

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Ruihua Wei

  Tianjin Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meinan He

CONTACT

13672135765; hmn509@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 29, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): August 19, 2028
• Study Completion (Estimated): September 20, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)