Prospective, single-masked, randomised, bilateral wear, dispensing trial to assess the visual performance of novel myopia management spectacle lenses in myopic adults.

Shanghai iSparX Medical Ltd0 个研究点目标入组 53 人开始时间: 2023年8月23日最近更新: 2023年11月6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 at least 18 years old and less than 45 years (inclusive), 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:
•Spherical equivalent less than or equal to -0.50 D
•Spherical component between -6.00 DS and 0 DS (inclusive).
•Astigmatic component between -2.00 DC and 0 DC (inclusive).
•Achieves 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)
•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

Shanghai iSparX Medical Ltd