A randomized, double masked, cross-over clinical trial to compare the vision performance of spectacles prescribed to 0.05D versus 0.25D steps in adults with myopia

nthalmic Pty Ltd0 个研究点目标入组 52 人开始时间: 2020年5月28日最近更新: 2023年9月4日

适应症

试验速览

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•Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
•Healthy adults aged 18 to 45 years of age (inclusive).
•Willing to refrain from using soft contact lenses for the duration of the study.
•Spherical refractive error between -1.00 and -6.00 D (inclusive) with cylinder power less than or equal to 1.00 D.
•Can attain good vision: Best corrected visual acuity of 6/6 or better in each eye.
•Willing to wear the study spectacles provided daily in lieu of their habitual spectacles for the duration of the study.
•Willing to attend the scheduled study visits and adhere to instructions.

•Be currently using topical ocular medication or have used topical ocular medication within 2 weeks of the first visit. Patients who are being treated bilaterally with marketed artificial tears can be considered, provided they discontinue use for 24 hours prior to each visit.
•History of clinically significant or progressive ocular disease in either eye that would affect vision e.g. keratoconus.
•Clinically significant anisometropia (difference in refractive power between the two eyes) of > 1.00D.
•Rigid gas permeable lens wearer (including orthokeratology).
•Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus.
•History of eye surgery or eye trauma within 6 months prior to enrolment in the study.
•History of corneal refractive surgery.
•The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.

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