Status:
UNKNOWN
Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses
Lead Sponsor:
Brien Holden Vision Institute
Collaborating Sponsors:
Essilor International
Hai Yen Eye Care
Conditions:
Myopia
Eligibility:
All Genders
8-13 years
Phase:
NA
Brief Summary
This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 child...
Detailed Description
Myopia has been considered as a 'global epidemic' owing to its rapid rise in prevalence across the world. Myopia significantly affects the quality of life of an individual socially by restriction of e...
Eligibility Criteria
Inclusion
- General inclusion criterion:
- \- Volunteer subject and guardian, fluent Vietnamese spoken, willing to follow the protocol and able to read, comprehend and sign the informed consent form.
- Study related inclusion criteria:
- Age: equal to or greater than 8 years and not older than 13 years.
- Spherical refractive error of -0.75 to -4.75 D in each eye (spherical equivalent), as measured by cycloplegic autorefraction.
- Astigmatism of not more than 1.50 D.
- Anisometropia of not more than 1.00 D.
- Best corrected visual acuity of equal or better than 0.05 LogMAR
- No strabismus by cover test at near and distance.
- Have the ability to comply with the protocol to get the reliable study measurements.
- Absence of ocular disease with full ophthalmic examination, such as retinal disease, cataract and ptosis. Good general health, without systemic or neurodevelopmental conditions. Without ocular or systemic medicine, which might affect myopia progression or visual acuity through known effects on retina, accommodation or significant elevation of intraocular pressure.
- No history of progressive addition lenses (PALs) or bifocal use and no prior use of contact lenses
Exclusion
- General exclusion criteria:
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere with study assessments.
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04048148
Start Date
May 31 2019
End Date
May 31 2021
Last Update
January 28 2021
Active Locations (1)
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1
Hai Yen Eye Care
Ho Chi Minh City, Vietnam, 700000