Corneal Transplantation
Conditions
Keywords
Corneal Transplantation
Brief summary
The goal of this clinical trial is to learn if a corneal preservation solution can safely and effectively preserve donor corneas for corneal transplantation in patients who need penetrating keratoplasty (PKP) or endothelial keratoplasty (EK). It will also learn about the safety of this corneal preservation solution. The main questions it aims to answer are: What is the donor viability rate on the day of transplantation, defined as the proportion of donor corneas with endothelial cell density (ECD) ≥2,000 cells/mm²? What is the corneal graft transparency rate 14 days after transplantation? What medical problems do participants have after transplantation? This is a single-center, prospective, single-arm study. Researchers will enroll 60 patients at Shandong Provincial Eye Hospital (Affiliated Eye Hospital of Shandong First Medical University). All participants will receive a donor cornea preserved in the corneal preservation solution for 2-7 days. Donor corneal ECD and hexagonality will be measured at the time of donor retrieval and on the day of transplantation. Donors with ECD ≥2,000 cells/mm² can be used for transplantation. Participants will be followed for 14 days after transplantation. There is no comparison group. Participants will: Undergo PKP or EK using a donor cornea preserved in the corneal preservation solution for 2-7 days. Have donor corneal ECD and hexagonality measured before transplantation. Be followed for 14 days after transplantation for graft transparency, ECD, graft thickness, epithelial healing, visual acuity recovery, secondary surgery, and adverse events. The results will provide evidence for the formal clinical use of this corneal preservation solution in China.
Interventions
PROCEDUREpenetrating keratoplasty
Corneal preservation solution used to preserve donor corneas for 2-7 days before PKP or EK.
Sponsors
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years, either sex; voluntary participation with signed informed consent; * Patients with keratoconus, bullous keratopathy, various corneal dystrophies, various corneal degenerations, corneal leucoma, infectious keratitis with relatively localized lesions and without severe hypopyon, and patients requiring secondary corneal transplantation due to graft opacity, graft dislocation, or graft infection; * The above patients must require penetrating keratoplasty (PKP) or endothelial keratoplasty (EK); * Able to communicate well with investigators and comply with the requirements of the entire trial; * Patients not currently participating in other clinical research trials; * Other patients deemed eligible for enrollment after evaluation by the investigators.
Exclusion criteria
* Patients with severe glaucoma, severe cataract, or severe iridocyclitis; * Patients with poor general condition; elderly high-risk patients; * Patients with mental disorders or other conditions deemed unsuitable for study participation by the investigators; * Patients who have completed participation in another drug or medical device clinical trial less than one month prior to enrollment; * Patients with other ocular diseases who are deemed unsuitable for inclusion after evaluation, such as severe corneal vascularization, severe limbal stem cell deficiency, or adherent corneal perforation, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor Corneal Viability Rate | On the day of corneal transplantation | Proportion of donor corneas with endothelial cell density (ECD) ≥2,000 cells/mm² after preservation with the investigational corneal preservation solution. |
| Corneal Graft Transparency Rate | 14 days after corneal transplantation | Proportion of corneal grafts with a corneal graft transparency score ≥2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Donor Corneal Endothelial Hexagonality | On the day of corneal transplantation | Percentage of hexagonal endothelial cells in the donor cornea. |
| Corneal Graft Endothelial Cell Density | 14 days after corneal transplantation | Endothelial cell density of the corneal graft. |
| Corneal Graft Thickness | 14 days after corneal transplantation | Thickness of the corneal graft. |
| Graft Epithelial Healing | 14 days after corneal transplantation | Status of corneal graft epithelial healing. |
| Postoperative Visual Acuity Recovery | 14 days after corneal transplantation | Recovery of visual acuity after corneal transplantation. |
Countries
China
Outcome results
None listed