Clinical trials to evaluate the efficacy and safety of Scleral contact lens,OPS01

Tasaka Tetsuya0 个研究点目标入组 25 人2023年9月4日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Corneal astigmatism that cannot use existing RGP contact lenses and soft contact lenses.
发起方: Tasaka Tetsuya
入组人数: 25
状态: 进行中（未招募）
最后更新: 2年前

暂无简介。

注册库

who.int

开始日期

2023年9月4日

结束日期

待定

最后更新

2年前

研究类型

Interventional

发起方

Tasaka Tetsuya

•1\) 18 years of age or older at the time consent acquisition.
•2\) The patient with corneal astigmatism in the objective eye that prevents the use of RGP contact lenses due to foreign body sensation, eye pain, or lens dropout.
•3\) Corneal astigmatism (keratoconus, pericyte corneal degeneration, post surgical, etc.) that cannot be corrected by either glasses or soft contact lenses (visual acuity of 0\.7 or better) in the objective eye.
•4\) The best corrected visual acuity of the subject eye at the time of screening is between 0\.01 and 0\.7\.

•1\) Existing vision correction methods (glasses, soft contact lenses, RGP contact lenses, etc.) are able to correct vision to 0\.7 or better (fractional visual acuity) in the objective eye and provide satisfactory results with no problems in terms of wearing comfort.
•2\) Patients with a history of allergic reactions to soft or RGP contact lenses or to the contents of contact lens care products.
•3\) Patients with a history of corneal transplantation in the objective eye.
•4\) Patients with corneal opacity in the objective eye, and the investigator determines that the corneal opacity covers the visual field area and cannot be expected to be corrected by a vision correction device.
•5\) Patients with a history or suspected history of glaucoma in the objective eye.
•6\) Patients with acute or subacute inflammation or infection in the anterior eye as described below
•\- Bacterial, fungal or viral keratitis
•\- Autoimmune corneal ulcer
•\- Conjunctivitis
•\- Scleritis