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Novel spectacle lenses versus single-vision spectacle lenses on the progression of myopia in children: A randomised clinical trial

Novel spectacle lenses versus single-vision spectacle lenses on the progression of myopia in children: A randomised clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000476
Enrollment
Unknown
Registered
2009-08-04
Start date
2009-08-01
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

Group E:Iteration E
Group G:Iteration G
Group F:Iteration F
Group H:control group
Total:Single-vision spectacle lenses (differing only from commercially-available lenses by slightly steeper front surface curvature) fitted to commercially-available frames

Sponsors

Zhongshan Ophthalmic Center,Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Be male or female between 6 and 12 years old; 2. Be myopic (short-sighted) -0.75 D to -3.50 D with astigmatism no more than -1.50 D; 3. Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator; 4. Be willing to wear only the spectacles provided by the Investigators; 5. Have ocular health findings considered to be "normal"; 6. Have vision correctable to at least 6/9.5 or better in each eye with spectacles.

Exclusion criteria

Exclusion criteria: 1. A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 2. Be anisometropic by more than 1.00 D; 3. Astigmatism more than -1.50 D in either eye; 4. Had strabismus and/or amblyopia; 5. Had previous eye surgery (including strabismus surgery); 6. Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes; 7. Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids; 8. Worn bifocal or progressive addition spectacles in the previous 12 months; 9. Worn orthokeratology lenses in the previous 12 months; 10. Current orthoptic treatment or vision training; 11. Any anatomical, skin or other condition that would impact on the wearing of spectacles; 12. Current enrolment in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Cycloplegic autorefraction;

Countries

China

Contacts

Public ContactJian Ge
gejian@mail.sysu.edu.cn+86 020 87330351

Outcome results

None listed

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