Corneal TransplantationNCT07874568
Safety and Efficacy of Corneal Preservation Solution for Corneal Transplantation
A study testing penetrating keratoplasty in people with Corneal Transplantation, run by Shandong Branden Med.Device Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- penetrating keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to 18 Feb 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Corneal Preservation Solution
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.
Read more
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.
- Conditions
- Corneal Transplantation
- Being tested
- penetrating keratoplasty
- Keywords
- Corneal Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penetrating keratoplastyProcedure or surgery
Corneal preservation solution used to preserve donor corneas for 2-7 days before PKP or EK.
| Study group | Role | What they receive |
|---|---|---|
| Corneal Preservation Solution Group | Experimental | Participants with corneal diseases requiring penetrating keratoplasty (PKP) or endothelial keratoplasty (EK) receive a donor cornea preserved in the corneal preservation solution for 2-7 days. Donor corneal endothelial cell density (ECD) and hexagonality are measured at the time of donor retrieval and on the day of transplantation. Only donor corneas with ECD ≥2,000 cells/mm² are used for transplantation. All participants are followed for 14 days after transplantation. The primary outcomes are the donor viability rate on the day of transplantation and the corneal graft transparency rate at 14 days after transplantation. Secondary outcomes include donor corneal endothelial hexagonality, ECD, graft thickness, graft epithelial healing, visual acuity recovery, secondary surgery (retransplantation) rate, and adverse events. There is no comparator arm. Receives: Procedure: penetrating keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor Corneal Viability Rate
Proportion of donor corneas with endothelial cell density (ECD) ≥2,000 cells/mm² after preservation with the investigational corneal preservation solution.
Measured: On the day of corneal transplantation
Corneal Graft Transparency Rate
Proportion of corneal grafts with a corneal graft transparency score ≥2.
Measured: 14 days after corneal transplantation
Secondary outcomes (5)
Donor Corneal Endothelial Hexagonality
Percentage of hexagonal endothelial cells in the donor cornea.
Measured: On the day of corneal transplantation
Corneal Graft Endothelial Cell Density
Endothelial cell density of the corneal graft.
Measured: 14 days after corneal transplantation
Corneal Graft Thickness
Thickness of the corneal graft.
Measured: 14 days after corneal transplantation
Graft Epithelial Healing
Status of corneal graft epithelial healing.
Measured: 14 days after corneal transplantation
Postoperative Visual Acuity Recovery
Recovery of visual acuity after corneal transplantation.
Measured: 14 days after corneal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 Nov 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874568
- Sponsor's protocol ID
- 2024-11-02
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No