An estimated 12.7 million people in the world are blind because of their cornea, the clear outer layer of the eye
Scientists in Sweden have developed an implant, made of collagen from pig skin, that resembles the human cornea of the eye. The experimental implant significantly improved or restored vision in 20 people with defective corneas, most of whom were previously blind. In fact, in some cases of patients, the restoration of their vision was complete (grades 20/20).
His researchers Linköping University and the company LinkoCare Life Sciences AB, who made the relevant publication in the biotechnology journal “Nature Biotechnology”, hope their achievement will give hope to those suffering from impaired vision or corneal blindness by offering them a biomechanical implant as an alternative to transplanting a human cornea from a donor. Such grafts are often rare.
“Our results show that it is possible to develop a biological material that meets all the criteria for use as human implants, which can be mass-produced and stored for up to two years, thus making it available to even more people with vision problems. This allows us to overcome the problem of lack of corneal tissue from donors“, said the professor Neil Lagalley of the Linköping Department of Biomedical and Clinical Sciences.
An estimated 12.7 million people in the world are blind because of their cornea, the outer clear layer of the eye, which can be damaged by disease or injury. So far, the only way to restore vision is a transplant, which happens to only one in 70 patients. Additionally, most people who need such a transplant live in low- and middle-income countries, where access to transplants is inherently very limited.
“The safety and efficacy of biotechnology implants are at the core of our work. We have gone to great lengths to ensure that our invention becomes widely available and affordable for everyone, not just the rich. That is why this technology can be used in all parts of the world“, said Associate Professor Mehrad Rafat of Linköping’s Department of Biomedical Engineering, designer of the implants, as well as founder and CEO of the company LinkoCare Life Sciences AB that produces them.
The human cornea consists mainly of the protein collagen. To create the laboratory cornea, the researchers used collagen molecules from pig skin (a by-product of the food industry that is widely available and cheap), which had been purified and mass-produced for human use. Finally, a durable and transparent material is produced that can be transplanted into the eye. While corneas from donors must be transplanted within just two weeks, lab-grown corneas have up to two years after they are created.
The researchers also developed a new minimally invasive method to treat keratoconus, a condition in which the cornea becomes so thin that it can lead to blindness. Until now, a patient’s keratoconus at an advanced stage had to be surgically removed and replaced with a donor graft, through a procedure that is invasive and only performed in specialized medical centers.
“A less invasive method will be able to be used in more hospitals, which will therefore help more people. With our method, a surgeon does not need to remove the patient’s tissue. Instead, through a small incision made by laser or by hand, the implant is inserted into the existing cornea“, said Dr. Lagali.
The technique was first successfully tested in pigs and then piloted in 20 people in Iran and India (two countries with a large number of patients with corneal blindness), where it proved to be simpler and safer than a conventional corneal transplant. The procedures to insert the laboratory implant showed no complications, and a treatment of only eight weeks with immunosuppressive drugs (drops) – and not years as in the case of conventional transplantation – was enough to prevent rejection of the implant. Its thickness and curvature were restored to normal levels.
Before the operation, 14 of the 20 patients were blind, while after two years none were blind anymore. In fact, three of those who were blind before had perfect vision after the operation.
The researchers are not yet sure what the final cost of the new method will be, but they estimate it will be lower than a regular transplant. A larger clinical study needs to be conducted, however, before regulatory authorities give permission to use the new method. Also to be investigated is whether the new technology can be used in other ophthalmological diseases, as well as whether the implant can be made more effective through individual adaptation to each patient.
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