None listed
Conditions
Interventions
Medical Device : As single group intervention model, the corneal prosthesis (C-Clear) was implanted during penetrating keratoplasty.
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity;Measurement of corneal thinckness;Examination of optic disk and nerve fibre layer;Examination of retina | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure measure | — |
Countries
Korea, Republic of
Contacts
Public ContactSanghyu Nam
Asan Medical Center
Outcome results
None listed