The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens (NCT05886348) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
China249 participantsStarted 2023-07-31
Plain-language summary
The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.
Who can participate
Age range7 Years ā 13 Years
SexALL
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Inclusion criteria
ā. Participant and parent (or guardian) are able and willing to provide consent
ā. Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements
ā. Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to
ā. Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study
ā. Age at time of parent or guardian consent and participant assent: 7 - 13 years old
ā. Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.
ā. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye
ā. Cycloplegic autorefraction anisometropia of 1.50 D or less
Exclusion criteria
ā. Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops
ā. Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development
ā. (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study.