A phased prospective, bilateral wear clinical trial to compare the visualperformance and wearability of prototype ophthalmic lenses andcommercially available myopia control spectacles among the age group of 18 to 35 years (The Calvin Study-part 1 of 2).

Brien Holden Vision Institute0 个研究点目标入组 27 人开始时间: 2021年10月21日最近更新: 2021年10月26日

适应症

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•Age in complete years ranging from 18 to 35 years, male or female.
•Myopic spherical equivalent non-cycloplegic subjective refractive error between -0.50D to -6.50D and
•cylinder up to and including -0.75DC
•Vision of 6/7.5 (20/25) or better in each eye with or without correction
•Able to read and comprehend English and give informed consent as demonstrated by signing a record
•of informed consent.
•Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
•Have ocular health findings considered to be normal”.

•Have strabismus and/or amblyopia.
•Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea,
•conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
•Use of or a need for any systemic medication or topical medications which may alter normal ocular
•findings / are known to affect a participant’s ocular health / physiology or contact lens performance
•either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
•Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and
•autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and
•systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not
•automatically exclude prospective participants.
•Eye surgery within 12 weeks immediately prior to enrolment for this trial.
•Previous corneal refractive surgery.
•Known allergy or intolerance to ingredients in any of the clinical trial products.
•Currently enrolled in another clinical trial.
•Pregnancy*.
•The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the
•clinical trial requirements or it is believed to be in the participant’s best interests.
•*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.

发起方

Brien Holden Vision Institute