Feasibility study of the UV-Femtosecond Laser Assisted Lenticular Extraction - N/A

Alcon laboratories India pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•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

•- 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
•- Other protocol specified exclusion criteria may apply

发起方

Alcon laboratories India pvt Ltd