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
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0007652
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best corrected visual acuity;Measurement of corneal thinckness;Examination of optic disk and nerve fibre layer;Examination of retina
- Secondary Outcome Measures
Name Time Method Intraocular pressure measure