Single-center, Single arm, Prospective, Pivotal Clinical Study to evaluate the safty and efficacy of Corneal prosthesis (C-Clear) in patients with vision loss due to congenital or acquired corneal damage who are unsuited to donated corneal tissue

Asan Medical Center0 个研究点目标入组 12 人开始时间: 待定最近更新: 2022年10月24日

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•1) Adult with vision loss (less than ETDRS Letter Score 35) due to congenital or acquired corneal damage who are unsuited to donated corneal tissue.
•2) Adult having normal intraocular pressure.
•3) Adult who had not penetrating keratoplasty via donated corneal tissue in the past year.
•4) If a woman of childbearing age, a woman consenting to the use to one of suitable contraceptive measures during the clinical study.

•1) Patient having a retina or optic nerve diseases.
•2) Patient with uncontrolled eye inflammation by a drug.
•3) Patient with a medical history of malignant tumor in eye or its surroundings.
•4) Patient with the target eye for the penetrating keratoplasty is a last eye.
•5) Patient having a unsuitable function of eyelid.
•6) Patient having corneal thinckness of the target eye for the penetrating keratoplasty is less than 400 micrometer or over 1200 micrometer.
•7) Patient with a medical histroy of hypersensitivity reaction to iridodilator.
•8) Patient with a medical histroy of keloid.
•9) A woman of childbearing age having pregnancy or planning pregnancy, and a nursing woman.
•10) Patient with a mental disease.
•11) Patient with a serious general disease.

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