An Evaluation of Transepithelial Photorefractive Intrastromal Cross-linking (pixl) for the Treatment of Low Myopia

Avedro Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Provide written informed consent;
•2.Willingness and ability to follow all instructions and comply with
•schedule for follow-up visits;
•3.Having BSCVA of 20/32 or better;
•4. Having manifest myopic refractive error of -0.75 D to -4.0 D, with refractive cylinder <=0.50 D, with stable refractive error for 12 months as demonstrated by a change of <= 0.50 D MRSE.
•5. Contact Lens Wearers Only: Discontinue use of contact lenses according to the table below, prior to the preoperative examination, and through the day of surgery; All contact lens wearers must demonstrate a stable refraction (within Â±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated

•1. A known allergy to the test article(s) or their components;
•2. Corneal pachymetry that is < 475 microns at the thinnest point
•measured by Pentacam in the eye to be treated;
•3. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
•a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
•b. Clinically significant corneal scarring in the cross-linking treatment zone that in the investigatorâ??s opinion, will interfere with the cross-linking procedure;
•c. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated;
•4. Pregnancy (including plans to become pregnant) or lactation during the course of the study;
•5. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
•6. Patients with a current condition that, in the investigatorâ??s opinion, would interfere with or prolong epithelial healing;
•7. A history of previous intra-ocular surgery or previous corneal surgery (including refractive surgical procedures) in the eye to be treated.

发起方

Avedro Inc