Prospective, single-masked, randomised, bilateral wear, dispensing trial to assess the visual performance of spectacle films in myopic young adults

nthalmic Pty Ltd0 个研究点目标入组 44 人开始时间: 2021年9月17日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Be greater than or equal to 18 years old but less than or equal to 40 years old, male or female.
•Willing to comply with the clinical trial as directed by the Investigator.
•Have ocular health findings considered to be normal” and which would not prevent the participant from wearing spectacle lenses.
•Myopic spherical equivalent correction less than or equal to -0.75 D
•A cylindrical correction greater than or equal to -2.00DC
•Have best-corrected visual acuity at least 6/7.5.

•Any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would cause vision fluctuations.
•Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens 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 spectacle frames .
•Currently enrolled in another clinical trial.
•Pregnancy at time of enrolment - verbal report sufficient
•The Investigator may, at their 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.

发起方