Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

NCT ID: NCT04048148

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-05-31

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 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.

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 employment in various fields and economically by additional cost for eye care and spectacles and contact lenses (Lim, Gazzard et al. 2009). In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which can could lead to blindness. Several optical and pharmaceutical strategies were developed over the recent years that could control or slow the progression of myopia.

It has been shown that persistent myopic defocus constantly applied on the whole retina has a beneficial effect on myopia progression, i.e. decrease in myopia progression (Anstice and Phillips 2011, Cheng, Woo et al. 2011, Ehsaei, Chisholm et al. 2011). In addition, a meta-analysis on the efficacy of non-invasive optical treatment strategies for myopia control reported prismatic bifocals to have the best outcome (Cheng, Woo et al. 2011). Therefore, test lenses were designed to increase the area and amount of myopic defocus on the retina without compromising vision.

Thus, this study aims to evaluate the efficacy of test lenses to reduce the progression of myopia by either reducing the myopia progression rate per year and/or reducing the elongation of eyeball through myopic defocus compared with SVL. A total of 120 healthy children aged 8 to 13 years will be recruited to participate in a double-masked cross-over clinical trial. Cycloplegic autorefraction will be the primary measure for myopia progression and axial length will the secondary outcome measure. Visual acuity will also be compared between test lens and control lens to determine the quality of vision using test lens.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Novel myopia control lenses

This group will be randomized to wear test lenses for 6 months followed by control lenses for 6 months and then test lenses for another 6 months

Group Type: OTHER

Novel designed myopia control spectacle lenses

Intervention Type: DEVICE

A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.

Single vision lenses

This group will be randomized to wear control lenses for 6 months followed by test lenses for 12 months

Group Type: OTHER

Novel designed myopia control spectacle lenses

Intervention Type: DEVICE

A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.

Interventions

Novel designed myopia control spectacle lenses

A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• 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 Criteria

• Vulnerability of the subject,
• Participation in another study which might have an influence on vision or interfere with study assessments.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essilor International

INDUSTRY

Sponsor Role: collaborator

Hai Yen Eye Care

INDUSTRY

Sponsor Role: collaborator

Brien Holden Vision Institute

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Weng

Senior Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Padmaja Sankaridurg, PhD

Role: STUDY_DIRECTOR

Brien Holden Vision Institute

Locations

Hai Yen Eye Care

Ho Chi Minh City, , Vietnam

Countries

Vietnam

References

Sankaridurg P, Weng R, Tran H, Spiegel DP, Drobe B, Ha T, Tran YH, Naduvilath T. Spectacle Lenses With Highly Aspherical Lenslets for Slowing Myopia: A Randomized, Double-Blind, Cross-Over Clinical Trial: Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2022. Am J Ophthalmol. 2023 Mar;247:18-24. doi: 10.1016/j.ajo.2022.10.021. Epub 2022 Nov 5.

Reference Type: DERIVED

PMID: 36347276 (View on PubMed)

Other Identifiers

VCRTC2019-01

Identifier Type: -

Identifier Source: org_study_id