|Year : 2018 | Volume
| Issue : 8 | Page : 1055-1057
The Barcelona principles: Relevance to eye banking in India and the way ahead
Santosh G Honavar
Editor, Indian Journal of Ophthalmology, Editorial Office: Centre for Sight, Road No 2, Banjara Hills, Hyderabad - 500 034, Telangana, India
|Date of Web Publication||23-Jul-2018|
Dr. Santosh G Honavar
Editor, Indian Journal of Ophthalmology, Editorial Office: Centre for Sight, Road No 2, Banjara Hills, Hyderabad - 500 034, Telangana
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Honavar SG. The Barcelona principles: Relevance to eye banking in India and the way ahead. Indian J Ophthalmol 2018;66:1055-7
|How to cite this URL:|
Honavar SG. The Barcelona principles: Relevance to eye banking in India and the way ahead. Indian J Ophthalmol [serial online] 2018 [cited 2018 Dec 15];66:1055-7. Available from: http://www.ijo.in/text.asp?2018/66/8/1055/237310
| The Barcelona Principles|| |
The Barcelona Principles – a path-breaking agreement on the ethical use of donated human tissue for ocular transplantation, research, and future technologies – was signed at the 2018 World Ophthalmology Congress in Spain [Table 1]. Developed by the Global Alliance of Eye Bank Associations in conjunction with the International Council of Ophthalmology, International Agency for the Prevention of Blindness, The Cornea Society, Asian Eye Bank Association, European Eye Bank Association, Eye Bank Association of America, Eye Bank Association of Australia and New Zealand, Eye Bank Association of India (EBAI), the Pan American Association of Eye Banks, and ophthalmic communities spanning 89 nations, this global bioethical framework encompasses aspects of consent, donation, and equitable allocation of ocular tissue.
Intended to help augment eye-banking services without compromising on the moral and ethical aspects pertaining to the donor, the recipient, or the extended community, the document offers recommendations on areas of ethical ambiguity such as profitization and supply chains, the global movement of eye tissue, and partnering across borders. It lays framework for the management of altruistic and voluntary donations; their subsequent utility within ophthalmology; their use for research and development that seek to improve donation utility, reduce burden, and improve therapeutic options for recipients; their retention as a public resource for the shared benefit of all; their accessibility by waiting recipients with equitable allocation systems; and development of self-sufficient services without ethical compromise. It also endorses the current international consensus that prohibits trafficking and transplant tourism.
| A National Eye Banking System for India|| |
In the last couple of decades, the concept of credible and quality-conscious eye banking seems to have gained some good momentum in India. While the annual collection of corneas has nearly tripled from 18,690 in 2001 to 52,758 in 2015, the utilization rate seems to be in a limbo, between 40% and 45% (43% in 2015).,, We need to perform 100,000 corneal transplantations a year to have a positive impact on the alarming situation of treatable corneal blindness in India;, we could perform <25% (22,860) of the needed number in 2015. While this disparity is striking, what is shocking is the gross asymmetry between the regions of the country – about 75% of the annual collection was by the five states – Tamil Nadu, Gujarat, Maharashtra, undivided Andhra Pradesh, and Karnataka, and the same states performed about 70% of all corneal transplantations in India. Tamil Nadu and Andhra Pradesh are the hubs of several ophthalmology institutes of national repute; it is logical to deduce that a significant number of beneficiaries may have been referred to these institutes from the parts of the country where corneal transplantation services are not readily available. One of the key points in the Barcelona Principles is to develop “local/national self-sufficient services.” It is important to augment eye banking and corneal surgical services in regions where there is a disparate gap between the need for these services and their availability, and thus help achieve local and regional self-sufficiency.
With a modest utilization rate of 50%, we need about 200,000 corneas a year to achieve the target of 100,000 transplants – a steep 4-fold increase from the current levels. As was proposed by Dr. Rao in his Editorial in the Indian Journal of Ophthalmology in 2004, we need 50 fully equipped eye banks (five of these possibly as four regional and one national training facilities) distributed strategically across the country, each supported by 40 Eye Donation Centers (EDC) and 10 Hospital Cornea Retrieval Programs (HCRPs). A target of 50 eyes for every EDC and 200 eyes for each HCRP will meet the annual target of 4000 eyes for each eye bank and 200,000 nationally. This is possible if we achieve 1.5%–2% eye donation rate from eligible donors in India, given the annual crude death rate of 7.33 in 2017.
Strategic distribution of eye banks across the country, partnership with local socio-political organizations and hospitals, vertical integration with local/regional EDCs and cornea specialists, effective dissemination of information about voluntary eye donation, grief counseling to augment HCRP, maintenance of quality standards of eye banking, improved utilization of the acquired tissue by adapting cost-effective long-term preservation methods and optimized distribution, and buy-in by the local/regional stakeholders and the community at large are the keys to success of the eye bank movement. We have on record 8 eye bank training centers, 223 eye banks, and 477 EDCs in India, but most of them seem underutilized or dormant. Only 58 eye banks collect >100 eyes a year and 15 collect >1000 eyes a year. There is a need to audit the existing facilities, benchmark them, and upgrade/merge/realign some of them to help ensure that they remain healthy, viable, and productive. The financial outlay to establish an active national eye banking system was estimated to be Rs. 260 million in 2004, – it could be about Rs. 1000 million (Rs. 100 crores) now (if we were to incorporate state-of-the-art international standards of eye banking, training, and research as part of the system), yet eminently affordable. An independent and empowered statutory accreditation system and built-in stringent quality control and audit are essential to sustain the eye banking standards.
| Equitable Distribution|| |
Lopsided distribution of the corneas may result in the vulnerable groups being marginalized by the system and wastage of tissue when in excess of local demand. Some of the measures that may help in equitable distribution are as follows:
National cornea grid
The immediate need is to establish a National Cornea Grid integrating the stock position of corneas in excess of local demand at all the eye banks – a transparent and an interactive online portal accessible to the registered cornea surgeons to readily seek and procure cornea of appropriate quality for their patients in waiting. The EBAI – SightLife Cornea Distribution system has attempted to provide such a mechanism, but a National Grid may make it broad-based and transparent.
Unique identification number and national corneal transplantation registry
Assignment of a biometry-based Unique Identification Number (UIN) for every patient medically advised a transplant will help avoid multiple registrations of the same patient in several hospitals. UIN-based National Corneal Transplantation Registry will help track the recipients and the outcome irrespective of their location of postoperative follow-up.
Establishment of consensus-based priority criteria for corneal transplantation and triage and strict adherence to the same by all the eye banks are necessary to minimize potential misuse of corneas. With the relatively higher rate of anatomical and functional success of lamellar corneal procedures, the surgical indications have become softer and broader, and the sophisticated skills needed to perform such surgeries, and the investment in instrumentation have brought in an unavoidable commercial angle. Transplant tourism is a reality, with international patients seeking care at affordable health-care systems in India. Use of optical grade cornea for therapeutic and tectonic purposes is rampant. Ideally, priority stratification is for children <6 years, children 6–12 years with bilateral visual impairment, adults with bilateral visual impairment, children 6–12 years with unilateral visual impairment, and adults with unilateral visual impairment in that order. Once the availability of corneas improves, it may be useful to identify surgeries for nonpriority indications and international patients and bring them into the system rather than letting them be in the gray zone. A premium tissue processing fee for nonpriority indications and for international patients and for precut tissue for lamellar procedures may provide resources to the eye banks to help make them self-sufficient.
Independent and stand-alone eye banks
Hospital-based eye banks which collect cornea exclusively for their internal use cannot be wished away. However, the use of state, national, and nongovernmental resources to build eye banks mainly to sustain internal needs is to be identified and discouraged. Eye banks established with public funding should be independent, standalone, and should primarily meet the needs of the region with a robust mechanism for unbiased distribution of the collected corneas to a common waiting list of potential recipients.
| Quality is Paramount – training is the Key|| |
Availability of skilled cornea specialists is a very crucial rate-limiting link to eradicate avoidable corneal blindness in India. We need about 1000 well-trained and certified specialist cornea surgeons each to perform 100 transplants a year , and an infrastructure to train, employ, and sustain this highly skilled manpower. Appropriate case selection, adequate surgical skills, aggressive postoperative care, early identification of rejection, and its appropriate management will help optimize the outcome. Five-year graft survival for primary penetrating keratoplasty in an institutional setting in India is only 46.5% and the rate of postoperative blindness is 41.8%. Skill enhancement of the existing cornea surgeons to incorporate newer lamellar surgical techniques in their practice may help reduce the incidence of suture-related complications and graft rejection/failure and thus achieve better outcome.
| Conclusion|| |
As we observe the National Eye Donation Fortnight from August 25 to September 8, we need to contemplate on the current state of our eye banking system, reset our goals, align ourselves with the Barcelona Principles which EBAI is a signatory to, and aim at establishment of a geographically broad-based, administratively independent, self-sufficient, ethical, and robust National Eye Banking System. It should be supported by the National Cornea Grid, priority-weighted recipient list, mechanisms to ensure fair and equitable distribution, UIN-based Corneal Transplantation Registry, statutory accreditation, and an elaborate training, skill-enhancement and certification program for cornea specialists. These measures, if implemented spiritedly by a proactive and passionate leadership, may not only resolve the problem of treatable corneal blindness in India in the near future but also create a replicable global model for sustainable eye banking in developing countries.
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