Production and quality of corneal grafts
A corneal graft is made in accordance with TS U 32.5-35544302-001: 2013
The highly qualified staff of the Dnipropetrovsk department of the SE "Bioimplant", technological equipment and long positive work experience allow to produce modern and safe bioimplants of the world’s level. Scientific-production process is carried out using standard operating procedures.
SE "Bioimplant" the Ministry of HealthCare of Ukraine is the only manufacturer of corneal grafts in Ukraine.
The corneal grafts are registered in accordance with applicable law by the State Service of medication and medical aimed items (certificate of the state registration number is 13181/2013 since 9 October 2013) and approved for use in medical practice in Ukraine. Today in Ukraine a corneal graft is the safest replacement of a damaged by injuries or diseases cornea of children and adults.
A part of the eye, called keratolimbal disk, is selected according to the world’s standards, so that multiple biological and virological studies are held, and studies of endothelial cell layer, which allows to predict the outcome of the upcoming surgery.
Producing a corneal graft goes through several stages:
1. Selection of the donor, which includes the study of the pathological history of the potential donor, the study of its social background, physical examination, direct examination of the eye tissue, obligatory serological testing.
2. Eyeball fragment sampling – the keratolimbal disk.
3. Biological study and additional testing of microbial contamination of the liquid with keratolimbal disk.
4. Microscopic study of the functional state of the endothelium.
5. Procession, conservation and preservation of the cornea.
6. Microbiological monitoring of the preserved cornea condition.
A corneal graft has the highest percentage of transparent engraftment, when it is used the risk of opacity appearance is significantly reduced.
New production technology and the storage biomaterial system allow domestic surgeons-ophthalmologists promptly treat patients with severe diseases of the cornea (keratoconus, dystrophies, burns and dystrophic walleyes (opacities), traumatic defects, as well as traumatic and postoperative scars of the cornea).
Using a corneal graft is determined by the type of operation that is carried out (penetrating keratoplasty, endothelial keratoplasty or anterior and posterior lamellar keratoplasty), which in its turn depends on the pathology of the patient's cornea.
Thanks to all of the above, a corneal graft is a high quality and safe medical product used to provide specialized eye care with the restoration of work capacity of patients and improve their quality of life after serious damage, injuries, and many destructive diseases that require surgical intervention.