Phase
Condition
Myopia
Treatment
DG1 Spectacle Lens
Single Vision Spectacle Lens
Clinical Study ID
Ages 7-10 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject and parent (or guardian) able and willing to provide assent and consentrespectively.
The subject and parent (or guardian) must attend required study visits and adhere tostudy requirements.
Parent (or guardian) understands and accepts random allocation of grouping, and thatsubject and parent (or guardian) will not be told the group which the subject israndomized to.
The subject is able and willing to wear provided frames and lenses (spectacles), foran average of 10 hours per day for the entirety of the study.
Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10years old (inclusive).
Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 Din each eye at the screening visit.
Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at thescreening visit.
Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D orless at the screening visit.
Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to orbetter than log MAR 0.10 in each eye at the screening visit.
Exclusion
Exclusion Criteria:
Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate ortropicamide eye drops.
Subjects with ocular or systemic abnormalities that might be expected to affectvisual functions or refractive development.
Subjects who have received treatment of myopia control pharmaceutical medication (e.g., atropine), myopia control contact lenses, other myopia control spectacles,orthokeratology lenses, progressive addition lenses, bifocal lenses, or singlevision contact lens prior to entry into the study or during the duration of thestudy.
Subjects with, or a medical history of, strabismus.
Subjects with a medical history of binocular vision abnormalities or accommodationabnormalities based on the opinion of the investigator.
Subjects with, or history of, amblyopia.
Subjects who have participated in a clinical trial within 30 days prior to entryinto this study or during participation.
Subjects with a history of intraocular surgery.
Subjects who, in the judgment of the investigator, have any emotional, physiologic,or anatomical condition which may preclude participation in this study or provide aninappropriate landscape for the intended study treatment.
Subjects with pathological myopia (myopia that leads to structural changes in theposterior segment of the eye including posterior staphyloma, myopic maculopathy, andhigh myopia-associated optic neuropathy).
Individuals from the same household (i.e., siblings), employees (or family membersof employees) of the Principal Investigator/site, employees (or family members ofemployees) of the Sponsor, and non-readers.
Study Design
Connect with a study center
Irvine Vision Center
Irvine, California 92618
United StatesActive - Recruiting
Columbia Eye Associates & Family Focus Eye Care
Gainesville, Florida 32605
United StatesActive - Recruiting
Coan Eye Care and Optical Boutique
Ocoee, Florida 34761
United StatesActive - Recruiting
Illinois College of Optometry
Chicago, Illinois 60616
United StatesActive - Recruiting
Complete Eye Care of Medina
Medina, Minnesota 55340
United StatesActive - Recruiting
Oculus Research, Inc.
Garner, North Carolina 27529
United StatesActive - Recruiting
ProCare Vision Centers, Inc.
Granville, Ohio 43023
United StatesActive - Recruiting
EyeCare Professionals of Powell
Powell, Ohio 43065
United StatesActive - Recruiting
Southern College of Optometry
Memphis, Tennessee 38104
United StatesActive - Recruiting
Virginia Pediatric Eye Center
Virginia Beach, Virginia 23452
United StatesActive - Recruiting
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