Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate the safety and clinical performance of ABCcolla Collagen Ophthalmic Matrix used for anterior lamellar keratoplasty in patients suffering from corneal ulcer.
Participants will undergo keratoplasty using the investigational product and be followed up for 24-week observation (total of 10 times).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix | Device | Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of irreversible graft dissociation or irreversible graft rejection within 6 months. | Count the number of subjects with irreversible graft dissolution or irreversible rejection within 24 weeks, and calculate the incidence rate | After the surgery, patients will be examined for follow-up observation for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The extent of graft transparency | After examined via slit lamp by the clinical ophthalmologist, the graft transparency were graded from 0 to 4, which indicated transparency, slight turbidity, mild turbidity of matrix and visble iris, worsening turbidity with invisible iris, and invisible pupil, respectively. | 24-week follow-up visit. Totoa 9 times. |
Not provided
1. Inclusion criteria:
2. Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ming-Cheng Tai, MD | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Kaohsiung Veterans General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28579539 | Result | Huang YH, Tseng FW, Chang WH, Peng IC, Hsieh DJ, Wu SW, Yeh ML. Preparation of acellular scaffold for corneal tissue engineering by supercritical carbon dioxide extraction technology. Acta Biomater. 2017 Aug;58:238-243. doi: 10.1016/j.actbio.2017.05.060. Epub 2017 Jun 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| The extent of graft vascularization | After examined via slit lamp by the clinical ophthalmologist, the extent of neovascularization was grades 0 if there were none, 1-4 if neovascularization had grown into the corneal limbus, the border of graft, 2mm of the gtaft, and into the center of the graft, respectively. | 24-week follow-up visit. Totoa 9 times. |
| Infection recurrence | The recurrence was examined via slit lamp by the clinical ophthalmologist. | 24-week follow-up visit. Totoa 9 times. |
| The extend of corneal edema | After examined via OCT by the clinical ophthalmologist, the corneal edema were graded from none, mild, moderate and severe by the doctor. | 24-week follow-up visit. Totoa 9 times. |
| Best corrected vision acuity | Examied by the Optometer. | 24-week follow-up visit. Totoa 9 times. |
| Light sensitivity | The light perception was tested by the clinical ophthalmologist. | 24-week follow-up visit. Totoa 9 times. |
| Kaohsiung City |
| Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| D005128 |
| Eye Diseases |