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Assessment of myopia progression rates in children wearing either a multifocal centre near or single vision soft contact lens

Assessment of myopia progression rates in children wearing either a multifocal centre near or single vision soft contact lens

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001746
Enrollment
Unknown
Registered
2011-12-01
Start date
2011-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Myopia

Interventions

1:AIR OPTIX Aqua Multifocal Medium ADD
2:ACUVUE OASYS

Sponsors

Zhongshan Ophthalmic Centre
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 17 Years

Inclusion criteria

Inclusion criteria: Participants enrolled in the trial must:? Be accompanied by a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent; 1. Be experienced in wearing soft contact lenses; 2. At baseline, be within the age range of 10 to 17 years old inclusive; 3. Be of Chinese ethnicity; 4. At baseline, be myopic (short-sighted) up to -8.00 D of spherical equivalent; 5. Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 6. Have ocular health findings considered to be "normal" and which would not prevent the subject from safely wearing contact lenses; 7. Have distance vision correctable to at least 6/9.5 or better in each eye with study contact lenses.

Exclusion criteria

Exclusion criteria: Participants enrolled in the trial must NOT have: 1. Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; 2. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sj?grens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; 3. Eye surgery within 12 weeks immediately prior to enrolment for this trial; 4. Previous corneal refractive surgery; 5. Keratoconus; 6. A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 7. Had strabismus and/or amblyopia; 8. Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity; 9. Current orthoptic treatment or vision training; 10. Undergone atropine treatment for myopia control; 11. Worn bifocal or progressive addition spectacles in the previous 12 months; 12. Worn orthokeratology lenses in the previous 12 months; 13. Require anticholinergic medication for gastrointestinal or other conditions; 14. Pregnant or lactating females (as reported by subject or their parent/guardian); 15. Currently enrolled in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Cycloplegic autorefraction;Axial length;

Countries

China

Contacts

Public ContactXiang Chen
x.chen@brienholdenvision.org+86 20 87330386

Outcome results

None listed

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