Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes (NCT05888792) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes
Hong Kong118 participantsStarted 2023-07-29
Plain-language 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.
Who can participate
Age range4 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* SER: -0.75D or below in both eyes
* 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
* For children aged 4-6 years without past prescription forms,
* 4-5 years old: myopia of -0.75D or below in both eyes
* 6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
* Best-corrected visual acuity (VA) in both eyes:
* 4 - 6 years old: 0.20 logMAR (or its equivalent) or better
* 7-12 years old: 0.00 logMAR (or its 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
What they're measuring
1
Cycloplegic refraction change in spherical equivalent refraction (SER)