Corneal Surgery, Transplant Tissue, and Eye Banking

Introduction

Corneal transplant surgery is an effective option for some people affected by corneal disease (Wang et al. 2016) it is the most frequently performed type of transplant worldwide (Gain et al, 2015). There is a global need for corneal transplant surgery – with an est. 12.7 million waiting for a transplant (Gain et al, 2015) – across all age groups (Solomon, 2005).

One of the biggest barriers to corneal transplantation is access to ethically donated and allocated human corneal tissue (HCT) – which is managed through a service called Eye Banking. Worldwide, there is a shortage of HCT – with 53.3% of countries without practical access, and another 35.7% with satisfactory access (Gain et al, 2015). Countries without eye bank services are mostly located in Low and Middle Income Countries (LMIC) – where an estimated 90% of the world’s vision impaired reside. (WHO, 2010).

The reasons for poor access to HCT and eye bank services vary from country to country, although in LMIC poor access is due to a: lack of trained manpower (clinicians and eye bankers); no existing donation-on-death program; no local Tissue Acts; limited prioritisation within the wider health system to support service development; suboptimal quality of surgical supplies; and inequities in allocation.

Corneal tissue is unique, as it is neither a manufactured tissue nor an organ. It’s position, as a tissue which is ‘living’ like an organ but managed like a tissue (AAO statement, 2016) – means it needs to be classified differently. Unfortunately, legislative policy in some countries does not make this distinction – resulting in limitations to service development.

Addressing Corneal Surgery – by addressing tissue access

Access to corneal tissue remains a challenge in many parts of the world. This can be addressed by including corneal needs, and eye banking, within the short term and long term National or Regional Eye Health Plans. Such plans, need to be inclusive of:

• Confirmation/agreement from the ophthalmology community and stakeholders to develop corneal services long term (i.e. corneal surgical training programs/fellowships)
• Seeking a clear distinction between human tissue for ocular application, and other tissues, organs (AAO statement, 2016) and human biologicals.
• Process planning, to obtain corneal tissue ethically via adherence to a national Tissue Act, sector standards and technical recommendations, bioethical frameworks and WHO guiding principles regarding human tissues (biologicals).
• Long term donor-community education programs and donor registries (often done in combination with other tissues and organ education programs) to promote eye and organ donation.
• Development of national self-sufficient eye bank systems, through capacity development methods (or short-term importation until such time – with feasible ‘exit-plans’ in place). (Martin et al, 2017).
• Equitable distribution of tissue to the community through policy and practice.
• Examining the appropriateness of alternative tissue and engineering methods – if financially viable and appropriate, and evidence-based-research suggests these alternatives as viable.