Feasibility study of the UV-Femtosecond Laser Assisted Lenticular Extraction

Alcon laboratories India pvt Ltd1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2020年9月15日最近更新: 2023年6月14日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 20
试验地点: 1
主要终点: 1. Extraction of lenticule

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to obtain additional safety and feasibility data on the UV-Femto procedure. Currently, a similar procedure for refractive surgery is approved for treating myopia by removal of a corneal lenticule. However, the approved procedure utilizes IR light to create corneal incisions and the intrastromal lenticule, while UV-FS laser has the advantage of using UV light with a significantly lower pulse energy as compared with standard IR femtosecond lasers. The UV-FS laser has shown preliminary safety and feasibility in removal of lenticules in a high myopic treatment in a previous study.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 22.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Subject must be able to understand and sign an IRB/IEC approved Informed Consent form.
•Willing and able to attend all scheduled study visits as required per protocol.
•Myopia with sphere of -0.50 to -10.0 D cylinder <1.00 D (MRSE within -0.50 to -10.0 D).
•Other protocol defined inclusion criteria may apply.

排除标准

•Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply: a. they are currently pregnant, b. have a positive UPT result at Screening, c. intend to become pregnant during the study period, d. are breast-feeding. Subjects who become pregnant during the study will not be discontinued; however, data will be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
•Study eye unable to focus for imaging and/or treatment.
•Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator (including history of Herpes Simplex).
•Current use of medications with known ocular side effects and photosensitivity, including but not limited to: steroids, antimetabolites, Isotretinoin (AccutaneÂ®), Amiodarone hydrochloride (Cordarone),or Hydroxychloroquine (Plaquenil), Tetracyclincs, Nalidixic Acids, and Fluoroquinolones.