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Not yet recruitingNCT07846787Updated Sep 29, 2026

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

An interventional study of High-order Phase Element Array Microstructure Design Lens (H.O.P.E.) and 0.02% Atropine Sulfate Eye Drops in Myopia, sponsored by Ruihua Wei. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Ruihua Wei · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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%)

Read the detailed description

This study focused on 6-9-year-old young children as the research subjects, aiming to investigate 1. The effectiveness of using H.O.P.E. lenses alone and in combination with 0.02% atropine eye drops, in order to provide data support and clinical guidance for the clinical effectiveness and safety of the high-order phase unit (H.O.P.E.) array microstructure lenses in young children with myopia.

02

Conditions studied

  • Myopia

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Keywords

  • myopia
03

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
264 participants (estimated)

Study arms

  • Active comparator
    Group A (H.O.P.E. Lens Group)

    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.)

  • Active comparator
    Group B (0.02% Atropine group)

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

    Drug: 0.02% Atropine Sulfate Eye Drops

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

    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

  • DeviceHigh-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.

  • Drug0.02% 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.

05

What researchers measure

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.

    Time frame: 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

    Time frame: From enrollment to the end of treatment at 12 months

06

Study locations

1 site
  • Tianjin Medical University Eye Hospital
    Tianjin, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07846787
Lead sponsor
Ruihua Wei
Collaborators
Tianjin Medical University Eye Hospital
Responsible party
Ruihua Wei (Professor, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted
Sep 29, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Aug 19, 2028 (estimated)
Completion
Sep 20, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Meinan He
Contact
hmn509@tmu.edu.cn
13672135765
Ruihua Wei
principal investigator · Tianjin Medical University Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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