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Randomized controlled clinical trial for MyoLens in controlling progression of myopia in children

Randomized controlled clinical trial for MyoLens in controlling progression of myopia in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049024
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

Myopia

Interventions

Group 1:Wearing lenses Myolens 1
Group 2:Wearing lenses Myolens 2

Sponsors

Institute of Optometry and Vision Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 8 and 12 years old (including 8 years old and 12 years old); 2. Understand and sign the informed consent; 3. Agree to fulfill the follow-up schedule and be able to comply with all appointments specified in the study protocol during the study; 4. Agree to receive randomly assigned control or test lenses; 5. To be in good general health according to his/her and parent/guardian knowledge; 6. Combined ophthalmic best corrected visual acuity of +0.10 logMAR or better in each eye; 7. Moderate to low refractive error (-0.50 to -1.50D) and astigmatism (equivalent to -0.75DC, or less).

Exclusion criteria

Exclusion criteria: 1. Wearing contact lenses currently or within 3 months; 2. Currently or within 3 months of using bifocals, progressive multifocals, atropine, pirenzepine or any other myopia control treatment; 3. Frequent use of eye medications and artificial tears; 4. Currently used systemic drugs that may significantly affect contact lens wearing, tear film production, pupil size, accommodation or refractive status; 5. Known allergy to fluorescein, benzoate, proparacaine or tropamide; 6. A history of corneal ischemia, corneal ulcer, corneal infiltration, ocular viral or fungal infection or other recurrent ocular infection; 7. When the wearing distance is corrected in the far (4 meters) or near (40 cm) distance, the dominant strabismus is found by the masking and masking experiment; 8. Systemic or ocular diseases affecting eye health; 9. Keratoconus or irregular cornea; 10. For any given anterior segment ocular clinical sign, CCLRU grade >= 2; 11. Have pathological myopia; 12. Connective tissue diseases; 13. Subjects who are participating in or have participated in other clinical studies within two months before this trial; 14. Other circumstances that the investigator considers inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Spherical Equivalent;

Secondary

MeasureTime frame
Axial Length;

Countries

China

Contacts

Public ContactLan Weizhong

Hunan AIER Institute of Optometry

lanweizhong@aierchina.com+86 13725458845

Outcome results

None listed

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