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A randomized cross-over controlled trial on simultaneous defocus spectacle lens for myopia control

A randomized cross-over controlled trial for myopia control with spectacle lens designed to modify relative peripheral defocus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021002
Enrollment
Unknown
Registered
2019-01-24
Start date
2019-01-28
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Myopia

Interventions

Group1:Phase I: the spectacle lens designed to modify relative peripheral defocus
Phase II: single optical lens.
Group2:Phase I: single optical lens
Phase II: the spectacle lens designed to modify relative peripheral defocus.

Sponsors

Eye Hospital of Wenzhou Medical University, Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8 to 13 years; 2. Spherical refractive error of -0.75 to -4.75 D in each eye (spherical equivalent), as measured by 3. Cycloplegic autorefraction. 4. Astigmatism of not more than 1.50 D. 5. Anisometropia of not more than 1.00 D. Best corrected visual acuity of equal or better than 0.05 LogMAR (= 0.9 as Snellen)

Exclusion criteria

Exclusion criteria: 1. With strabismus by cover test at near or distance; 2. Vertical phoria; 3. Presence of any ocular disease that would influence refractive development, such as retinal disease, cataract and ptosis; 4. Presence of systemic or neurodevelopmental conditions that may influence refractive development; 5. Use of ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure; 6. Prior use of PALs or bifocal use or prior use of contact lenses.

Design outcomes

Primary

MeasureTime frame
Axial length;Cycloplegic autorefraction;

Secondary

MeasureTime frame
Subjective refraction;Visual acuity;

Countries

China

Contacts

Public ContactLijie Hou

Hangzhou Branch of Eye Hospital Affiliated to Wenzhou Medical University

hord@163.com+86 13506514838

Outcome results

None listed

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