Phase
Condition
Myopia
Treatment
Model-B Novel spectacle lens
Model-A Novel spectacle lens
Single vision spectacle lens
Clinical Study ID
Ages 7-13 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant and parent (or guardian) are able and willing to provide consent
Participant and parent (or guardian) ensure to attend required study visits andadhere to participant requirements
Parent or guardian understands and accepts random allocation of grouping, and thatparticipant and parent (or guardian) will not be told which group participant isallocated to
Participant willing to wear the study spectacles lens for a minimum of 12 hours perday for the duration of the study
Age at time of parent or guardian consent and participant assent: 7 - 13 years old
Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.
Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye
Cycloplegic autorefraction anisometropia of 1.50 D or less
Monocular best corrected distance visual acuity (BCDVA) equal to or better thanlogMAR 0.00 in each eye.
Exclusion
Exclusion Criteria:
Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide orcyclopentolate eye drops
Any ocular and systemic abnormalities might be expected to affect visual functionsor refractive development
(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 ofmyopia control such as contact lenses, orthokeratology lenses etc., progressiveaddition lenses, bifocal lenses, within 3 months. (c) Have received treatment ofmyopia control such as defocus spectacle lenses (difference between both eye'snon-cycloplegic autorefraction and lens-meter results of the respective lenses areequal or less than 0.50 D SER) etc. within one month prior to entry into this study.
Participant with clinically significant strabismus (including intermittent tropia)
Medical history of binocular vision abnormalities
Participant with amblyopia
Participation in a clinical trial within 30 days prior to entry into this study orduring participation
Previous intraocular surgery
Participant who, in the judgment of the Investigator, presence of any emotional,physiologic, or anatomical condition which may preclude participation in this studyor provide an inappropriate landscape for the intended study treatment.
Any medical treatment or medication which might have an influence on vision orinterfere with study assessments
Pathological myopia (myopia that leads to structural changes in the posteriorsegment of the eye including posterior staphyloma, myopic maculopathy, and highmyopia-associated optic neuropathy)
Study Design
Study Description
Connect with a study center
Beijing Tongren Hospital, Capital Medical University
Dongcheng, Beijing
ChinaSite Not Available
Guangzhou Aier Eye Hospital
Yuexiu, Guangzhou
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Nankai, Tianjin
ChinaSite Not Available
Beijing Tongren Hospital, Capital Medical University
Beijing,
ChinaSite Not Available
Guangzhou Aier Eye Hospital
Guangzhou,
ChinaSite Not Available
Eye and ENT Hospital of Fudan University
Shanghai,
ChinaSite Not Available
Shengyang He Eye Specialist Hospital
Shengyang,
ChinaSite Not Available
Tianjin Medical University Eye Hospital
Tianjin,
ChinaSite Not Available
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