Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

NCT04048148 | Unknown

• 1 other identifier: VCRTC2019-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Cycloplegic refraction

  Change in myopia progression measured by cycloplegic refraction (Diopters) using Shin Nippon Auto-refractor

  Up to 18 months

Secondary Outcomes (1)

• Axial length

  Up to 18 months

Study Arms (2)

Novel myopia control lenses

OTHER

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

Device: Novel designed myopia control spectacle lenses

Single vision lenses

OTHER

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

Device: Novel designed myopia control spectacle lenses

Interventions

Novel designed myopia control spectacle lenses DEVICE

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

Novel myopia control lenses; Single vision lenses

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Brien Holden Vision Institute: lead
• Essilor International: collaborator
• Hai Yen Eye Care: collaborator

Study Sites (1)

Hai Yen Eye Care

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 36347276 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Padmaja Sankaridurg, PhD

  Brien Holden Vision Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and their parents / guardians and investigators will be masked to their lens assignment. Test spectacles will be of similar appearance to control spectacles and will not be easily identified without specialized equipment. Test and control spectacles will be assigned a code (A or B) by the clinical coordinator and stored in a secure location.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Project Manager

Model Details: This is a mono-center, randomized, double-masked, cross-over study to evaluate if novel design lens can slow down the progression of myopia. A total of 120 healthy children aged between 8 years to 13 years with myopia (-0.75D to -4.75D) meeting the inclusion and exclusion criteria will be recruited. These children will be randomized to wear test lenses followed by control lenses (Group 1) or to wear control lenses followed by test lenses (Group 2). At the end of the 12 month period, all participants will wear test lenses for another 6 months. All children will be followed at 3-monthly intervals for 1.5 years to monitor for changes in axial length and 6-monthly for changes in cycloplegic autorefraction. The cross-over design allows to compare treatment effects between the two groups at 6 months, 12 months and at 18 months. In addition, at the end of the study, the treatment effects can be compared within subject as each subject will have worn both lenses and serves as his/her control.

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 7, 2019
• Study Start: May 31, 2019
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will become available mid 2021, starting 6 months after publication.

Locations

VN (1)