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A Clinical trial to evaluate the safety and efficacy of Maixiaoxing Myopia Management Glass in delaying myopia progression

A Clinical trial to evaluate the safety and efficacy of Maixiaoxing Myopia Management Glass in delaying myopia progression

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083894
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Test group:Wear Maixiaoxing Myopia Management Glass
Control group:Wear single-focus lenses

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Age =8 years old and =13 years old, with the written consent of the guardian, gender is not limited; 2. Under binocular astigmatism, the equivalent spherical diopter of objective refraction is between = -0.75 D and = -5.00 D, with astigmatism = 1.50D and refractive error of both eyes = 1.50D after the equivalent spherical diopter; 3. The best corrected visual acuity in both eyes is =1.0; 4. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of eye trauma or intraocular surgery that affects the wearing of frame glasses; 2. Clinically significant slit-lamp findings; 3. Abnormal results of fundus examination; 4. Abnormal IOP (IOP 21mmHg); 5. Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumor, eye trauma, and dominant strabismus; And any eye lesions that affect the visual function of the eye; 6. Patients with systemic diseases that cause immune deficiency (such as diabetes, Down syndrome, rheumatoid arthritis, psychiatric patients or other diseases that researchers deem unsuitable for wearing frame glasses); 7. Participants who have participated in clinical trials of non-ophthalmic drugs within three months or participated in clinical trials of ophthalmic drugs or devices in the past; 8. Used any myopia control products, such as orthokeratology lenses, multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses; Used atropine drugs, etc., but did not cover mydriatic drugs used in refractive examination; 9. Only one eye meets the inclusion criteria; 10. Those who cannot perform regular eye examination; 11. The researchers determined that other conditions did not qualify the candidates.

Design outcomes

Primary

MeasureTime frame
Axial length;

Secondary

MeasureTime frame
Equivalent sphericity lens degree;Axial length;Choroidal vascular density;

Countries

China

Contacts

Public ContactLihua Li

Tianjin Eye Hospital

tysgzxlccs@163.com+86 156 9224 5330

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026