Prospective, contralateral, randomised, crossover dispensing clinical trialto compare the myopia progression rate between a myopia control contactlens and single vision contact lenses

Brien Holden Vision Institute0 个研究点目标入组 10 人开始时间: 2018年2月14日最近更新: 2019年7月15日

适应症

试验速览

暂无简介。

•Aged between 6 years to 17 years (6 years and 17 years inclusive);
•Spherical equivalent -0.75 D to -3.50 D with cylinder no more than -1.00 D; anisometropia of less than or equal to 0.75D
•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent or have a parent / guardian who is able to give informed consent on the participant’s behalf.
•Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
•Have ocular health findings considered to be normal” and which would not prevent the subject from safely wearing contact lenses;
•Have vision correctable to at least 6/9.5 or better in each eye with study contact lenses.

•Participants enrolled in the trial must NOT have:
•pre-existing ocular irritation that would preclude contact lens fitting;
•any systemic or ocular condition or ocular injury that may preclude safe wearing of contact lenses;
•undergone corneal refractive surgery;
•Keratoconus
•a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics;
•at baseline, astigmatism more than 1.00 D in either eye;
•had strabismus and/or current ongoing amblyopia;
•any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity;
•current orthoptic treatment or vision training;
•eye injury or surgery within 12 weeks immediately prior to enrolment for this trial;
•undergone atropine treatment for myopia control;
•worn bifocal or progressive addition spectacles or anti-myopia contact lenses previously;
•worn orthokeratology lenses previously;
•require anticholinergic medication for gastrointestinal or other conditions;
•at baseline, be anisometropic by more than 0.75D;

发起方

Brien Holden Vision Institute