An interventional study of penetrating keratoplasty in Corneal Transplantation, sponsored by Shandong Branden Med.Device Co.,Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Shandong Branden Med.Device Co.,Ltd · Not applicable, Interventional, and Treatment
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.
Shandong Branden Med.Device Co.,Ltd is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: penetrating keratoplasty
Corneal preservation solution used to preserve donor corneas for 2-7 days before PKP or EK.
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.
Time frame: On the day of corneal transplantation
Corneal Graft Transparency Rate
Proportion of corneal grafts with a corneal graft transparency score ≥2.
Time frame: 14 days after corneal transplantation
Donor Corneal Endothelial Hexagonality
Percentage of hexagonal endothelial cells in the donor cornea.
Time frame: On the day of corneal transplantation
Corneal Graft Endothelial Cell Density
Endothelial cell density of the corneal graft.
Time frame: 14 days after corneal transplantation
Corneal Graft Thickness
Thickness of the corneal graft.
Time frame: 14 days after corneal transplantation
Graft Epithelial Healing
Status of corneal graft epithelial healing.
Time frame: 14 days after corneal transplantation
Postoperative Visual Acuity Recovery
Recovery of visual acuity after corneal transplantation.
Time frame: 14 days after corneal transplantation
Secondary Surgery (Retransplantation) Rate
Rate of secondary surgery or retransplantation.
Time frame: 14 days after corneal transplantation
Adverse Events and Serious Adverse Events
Incidence of adverse events (AEs) and serious adverse events (SAEs). Ocular-specific AEs include: 1) postoperative graft infection; 2) graft opacity; 3) graft rejection.
Time frame: 14 days after corneal transplantation
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Shandong Branden Med.Device Co.,Ltd