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Active (not recruiting) Not applicable NCT05888805

Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group

No applicable phase (e.g. observational)
Conditions: Myopia

Sponsor: The Hong Kong Polytechnic University

trial.available_in: БГ
Overview
The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) and a variant of DIMS (D2) spectacle lenses on controlling myopia progression in fast progressing myopic children.
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 the first 2 years. They will then be prescribed with a pair of D2 spectacle lens for an additional 2 years. D2 is the variant of Defocus Incorporated Spectacle lenses. It is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Who can participate
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
Interventions
DIMS spectacle lens
OTHER
Locations 1
Hong Kong (1)
School of Optometry, The Hong Kong Polytechnic University
Hung Hom
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Maximum age
12 Years
Healthy volunteers
No
Start date
29.07.2023
Completion date
31.12.2028
Registry ID
NCT05888805
Source
clinicaltrials.gov
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