Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Other: DIMS spectacle lens

• Registration Number: NCT05888805
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

Detailed Description

DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2023-07-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-02-28
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DIMS lens group	DIMS spectacle lens	Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.

Primary Outcome Measures

Name	Time	Method
Cycloplegic refraction change in spherical equivalent refraction (SER)	Baseline, 1st year and 2nd year	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.

Secondary Outcome Measures

Name	Time	Method
Axial length change	Baseline, 1st year and 2nd year	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.

Trial Locations

Locations (1)

School of Optometry, The Hong Kong Polytechnic University; 🇭🇰 Hung Hom, Hong Kong