Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope

Myopia Clinical Trial

Official title:

Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope: A Randomised Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888792
• Other study ID #: H-ZGET
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2023
• Source: The Hong Kong Polytechnic University
• Contact: Dennis Yan Yin Tse, PhD
• Phone: 852-27666096
• Email: dennis.tse[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy and performance of the variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Description:

The variant of Defocus Incorporated Spectacle lenses (DG2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time. Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (DG2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the DG2 lens and be monitored for another 12 months. In parallel, the DG2 treatment groups will continue their corresponding intervention for 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years. The changes in refractive errors and axial length in two groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: May 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• SER: -1.00D or below
• Documented history of fast progressing myopia, either in SER or AL
• SER progression: 0.50D/year or more
• AL elongation: 0.27mm/year or more
• Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
• Acceptance of random group allocation and the masked study design
• Anisometropia of 1.50 D or less
• Astigmatism of 2.00 D or less

Exclusion Criteria:

• Strabismus and binocular vision abnormalities
• Ocular and systemic abnormalities
• Prior experience of myopia control

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Variant of Defocus Incorporated Spectacle lens (DG2)
DG2 is a variant of Defocus Incorporated Spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously

Locations

Country	Name	City	State
Hong Kong	School of Optometry, The Hong Kong Polytechnic University	Hung Hom

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	HOYA Lens Thailand LTD.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic refraction change in spherical equivalent refraction (SER)	Cycloplegic SER (in diopter) will be measured using an open field autorefractor.; Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured	Baseline, 1st year and 2nd year
Secondary	Axial length change	Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer.; Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured	Baseline, 1st year and 2nd year