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Myopia is a common disorder, affecting approximately one-third of the US population and over 90% of the population in some East Asian countries. High amounts of myopia are associated with an increased risk of sight-threatening problems, such as retinal detachment, choroidal degeneration, cataracts, and glaucoma. Slowing the progression of myopia could potentially benefit millions of children. To date, few strategies used for myopia control have proven to be effective. Currently, there are four categories of myopia control treatments: atropine eye drops, multifocal contact lenses, multifocal eyeglasses, and orthokeratology (ortho-k). None of these modalities are US Food and Drug Administration-approved to slow myopia progression, they have been shown to slow the progression by approximately 50% with few risks. Both orthokeratology and soft bifocal contact lenses have shown to slow myopia progression by slightly less than 50% in most studies.
The Myolens progressive front soft contact lens is designed to slow down myopia progression in children, The Myolens lens is an aspheric design with a spherical back surface that provides clear vision, with a uniform round edge for excellent fit and optimum comfort.
The Myolens-CN is designed with a central for the near optics, while the Myolens-CF with a central for the distance optics, which progressively changes to far area and within a defined optical zone area while considering the movement up-down of the lens on the cornea.
The thought behind the design is that the center of the lens will not provide a full optical correction.
In the suggested study, both Myolens modalities CN and CF will be investigated in compare to the current approved treatment - MiSight.
Full description
Study Procedures:
Screening period (up to 3 weeks prior to enrollment)
Week 1 Day 1 (±3 days)
Treatment period (36 months)
Follow up period (4 weeks) End of study (EOS) visit will be conducted 4 weeks after EOT. Completion of the study will be considered as the completion of visit 36M which will the EOT visit for the subject and 4 weeks follow up. In case of early termination, EOS will be conducted upon time of termination (UNS). EOS visit procedures are equal to 36M visit procedures.
Enrollment
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Volunteers
Inclusion criteria
Be between 8 and 12 years of age inclusive at baseline examination.
The participant has been given a detailed, clear explanation concerning the study aspects and procedures.
The participant's parents or legal guardian have been given a clear explanation, then read, understood, and signed the informed consent form.
Willingness to adhere to protocol, agreement to maintain the visit schedule.
Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
Agreement to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 3-year study.
Subject with normal eyes who is not using any ocular medications.
Possess wearable and visually functional eyeglasses.
Be in good general health, based on his/her and parent's/guardian's knowledge.
Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 or 6/7.5) or better in each eye. (Lens power required limited to up to minus 10).
The manifest cylinder is less than or equal to 0,75D.
Meet the following refractive criteria determined by cycloplegic autorefraction at baseline (per eye):
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
66 participants in 3 patient groups
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Central trial contact
Cheli Gonnen; Avner Avrahami
Data sourced from clinicaltrials.gov
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