Clinical Research Directory

Safety and Efficacy of Corneal Preservation Solution for Corneal Transplantation

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.

Factors Influencing Corneal Donation in Palliative Care Unit

Today, there is a shortage of tissues such as corneas for a variety of reasons. However, it is possible to harvest tissues from people who are usually excluded from donation, particularly cancer diagnosed, by recruiting them into palliative care units. Corneal transplantation is a surgical procedure designed to improve the vision of many persons. A number of diseases now require corneal transplants, such as keratoconus. As with other organs, the shortage of donors remains a major obstacle to the use of this technique, a shortage which became much more acute during the health crisis linked to the pandemic caused by the SARS-CoV-2 virus. In 2022, 10615 participants were waiting for a transplant, but only 46.3% of them received one. Cornea removal differs from the removal of other organs. Firstly, there are fewer contra-indications. It can be performed on persons with chronic conditions that would usually exclude them from receiving other organs, such as cancer. As the cornea is not vascularised, the risk of damage is considered to be zero, except in cases of cancers of cerebral neurological origin or melanoma. Secondly, the donor's remains can be preserved for up to 24 hours after death. This makes it possible to recruit care services that are not usually involved in organ transplants, as these services provide new potential donor recruitment resources. This includes palliative care units. There is currently no French literature on corneal donation specifically in palliative care units. There is a lack of data on the factors that encourage or hinder donation. Based on our experience of corneal donation in our palliative care unit since 2020, the investigators are conducting a clinical study to evaluate the factors that facilitate or impede corneal donation in our hospital palliative care unit.

The German Keratoplasty Registry of the German Ophthalmological Society (DOG)

Aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in Germany. The Section Cornea of the German Ophthalmological Society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.

Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea

Optical Coherence Tomography (OCT) image data will be evaluated for image quality and used to test post-processing algorithms to improve detection sensitivity for ophthalmic diseases.

Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]

The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation. The goal is to improve graft survival by reducing pathological vessels through pre-treatment.

Timing of Glaucoma Drainage Device With Boston Keratoprosthesis

Boston keratoprosthesis (KPro) is a piece of specialized plastic that replace sick cornea (transparent structure at the front of the eye) in patients who have failed or those who are expected to have poor results with traditional corneal transplantation. While the Kpro can offer dramatic improvement in vision, it is also associated with several complications. Glaucoma (optic nerve damage due to high pressure inside the eye) is one of the most common complications after KPro surgery and can potentially cause irreversible vision loss. The implantation of a glaucoma drainage device (GDD), a tiny tube that drains the liquid inside the eye by bypassing the natural drainage system, is an effective option to lower the eye pressure in patients with KPro. Given the frequency and potentially devastating effects of glaucoma among KPro patients, some surgeons recommend to put in a GDD as a preventative measure. However, there is no consensus on when is the best timing to perform such surgery in relation to the Boston Kpro surgery. Hypothesis: For patients undergoing the Boston KPro surgery, implanting a GDD simultaneously, at the time of surgery, is more efficacious than at 6 months later, in the prevention of the progression of glaucoma and in maintaining better visual functions. Methods: The investigators aim to recruit 40 patients over 4 years. Recruited patients will be randomly assigned to 2 groups: 1) simultaneous GDD implantation at the Boston KPro surgery, and 2) GDD implantation 6 months after the Boston KPro surgery. Once recruited, patients will be followed before the KPro surgery, postoperative day 1, week 1, month 1, 3, 6 and 12. Standard ophthalmological exam will be performed at each visit. Additional non-invasive glaucoma tests and evaluation (visual fields and optic nerve photo) will be performed on day 1, month 1, 3, 6 and 12. For patients assigned to group 2, a GDD will be implanted 6 months after the KPro surgery. They will have additional follow-ups on post-GDD surgery day 1, week 1 and month 1. Results of visual acuity, visual fields, optic nerve evaluation and complications will be compared between the two groups to determine the better timing of GDD implantation.