Prospective, randomised, crossover, bilateral wear, dispensing trial to assess the visual performance of prototype myopia management films in myopic adults

nthalmic Pty Ltd0 个研究点目标入组 38 人开始时间: 2024年2月29日最近更新: 2024年9月2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 18 to 45 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.
•Currently wearing or have the need to wear single-vision spectacles to correct myopia.
•Meet the following criteria based on subjective refraction at Baseline:
•oSpherical equivalent less than or equal to -0.50 D
•oSphere component greater than or equal to -6.00 DS and less than or equal to 0 DS.
•oAstigmatic component greater than or equal to -2.00 DC and less than or equal to 0 DC.
•oAchieve at least 0.10 logMAR in each eye at 6 m and binocularly at 40 cm while wearing subjective distance refraction.

•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 ocular clinical trial.
•Pregnancy at time of enrolment (verbal report sufficient)

发起方