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Clinical trial to evaluate the safety and efficacy of two types of circular column modulated lenses for delaying the progression of myopia

Clinical trial to evaluate the safety and efficacy of two types of circular column modulated lenses for delaying the progression of myopia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054139
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-08-21
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Myopia

Interventions

Group 1:One point frame glasses
Group 2:Circular cylindrical mirror modulated frame glasses (compact)
Group 3:Circular cylindrical mirror modulated frame glasses (strong defocus)

Sponsors

Ophthalmology Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 to 13 years old, the written consent of the guardian is required, and the gender is not limited; 2. The spherical equivalent of objective refraction under binocular dilation is between -0.75D (inclusive) and -5.00D (inclusive) (based on the average value of objective refraction examination), and the subjective refraction of left and right eyes is the best Corrected visual acuity greater than or equal to 1.0; astigmatism less than or equal to 1.50D (refer to the subjective refraction before astigmatism), and anisometropia of both eyes after equivalent spherical lens is less than or equal to 1.50D; 3. Voluntarily participate in this clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of ocular trauma or intraocular surgery; 2. Clinically meaningful slit lamp findings; 3. Fundus examination results >=grade 2; 4. Abnormal intraocular pressure (intraocular pressure 21mmHg or intraocular pressure difference >=5mmHg); 5. Patients with other ocular diseases, such as uveitis and other inflammations, glaucoma, cataracts, fundus diseases, ocular tumors, ocular trauma, overt strabismus; and any ocular lesions that affect visual function; 6. Patients with systemic diseases that cause immunocompromised patients (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, psychiatric patients or other diseases that researchers think are not suitable for wearing glasses, etc.) ; 7. Those who have participated in drug clinical trials within 3 months; 8. Those who cannot conduct regular eye examinations; 9. Have participated in any myopia control clinical research trials within three months, previously used or are currently using hard contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.; 10. Overt strabismus; 11. Amblyopia in any eye; 12. The investigators determine that they cannot be selected.

Design outcomes

Primary

MeasureTime frame
Ocular axial length;

Secondary

MeasureTime frame
Spherical equivalent objective optometry after ciliary muscle paralysis;Main sensory optometry;

Countries

China

Contacts

Public ContactMao Xinjie

Eye hospital of Wenzhou Medical University

mxj@mail.eye.ac.cn+86 13705880472

Outcome results

None listed

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