Surgeons develop visionary plan to bring corneal transplants to developing countries

Dr. Waller (top left) looks on as Dr. Jain (a local eye surgeon, at microscope) and a local nurse assistant (left) transplant a cornea. Drs. Jindal and Patel observe

Dr. Waller (top left) looks on as Dr. Jain (a local eye surgeon, at microscope) and a local nurse assistant (left) transplant a cornea. Drs. Jindal and Patel observe

Many developing nations now have health care providers that offer specialty care. For example, kidney transplantation was practically nonexistent in low- and middle-income countries and end-stage renal disease was considered a death sentence until recent years.1-3 Since 2008, a renal transplant program launched in Guyana by Rahul M. Jindal, MD, PhD, MBA, FACS (coauthor of this article), and colleagues has carried out 26 living kidney transplants, numerous peritoneal dialysis catheter placements, and vascular access procedures for hemodialysis.1 Dr. Jindal’s team has delivered lectures and held press conferences to raise local physician and patient awareness of the transplant program. They also have initiated a public health project to train selected individuals living in each village (average education of 12th grade and above) in basic clinical skills, such as recording blood pressure and blood sugar measurements, and noting lifestyle modifications, including dietary practices, and hygiene levels, which will allow the student team to act as primary health care workers.1

More recently, the team established a successful, sustainable corneal transplant program in Guyana. To launch this program, Dr. Jindal and his colleagues used a private-public partnership (PPP) model, working with government agencies to attain sponsorship to help offset costs, build surgical capacity, establish an infrastructure for an eye bank, identify appropriate patients, and provide reliable follow-up. This article describes some of the key features of a successful corneal transplantation system, such as the establishment of accredited eye banks; the factors that influence the success of a corneal transplant program; how the authors successfully implemented the PPP model; and the lessons learned in developing this program.

Need in developing countries

Although the prevalence of blindness is greatest in developing countries, the availability of corneal transplant surgery and donor tissue is lowest in such places. As this disparity has become increasingly apparent to health officials, establishing eye banks in low-income countries has become a priority. Despite some efforts by various governmental and nongovernmental organizations, the supply of corneas falls short of the demand.4 Keratoprosthesis, use of an artificial cornea, may be an alternative to corneal transplant in a small percentage of the cases.5

Corneal opacities are cited as the third most common cause of blindness and represent 7 percent to 25 percent of all causes of blindness worldwide.6-8 Corneal blindness is more common in developing countries and is underreported, thus making it difficult to estimate its true prevalence.7 The epidemiology of corneal blindness varies by region and age and is dependent on the ocular diseases that are endemic to the geographic location. Corneal blindness is a leading cause of permanent visual impairment, as scarring and vascularization of the cornea cannot be reversed.9

Most causes of corneal blindness in developing countries are either treatable or preventable.10 According to a 2005 study, the diseases that most frequently lead to corneal blindness include trachoma, onchocerciasis, leprosy, ophthalmia neonatorum, and xerophthalmia.8 In a study of 12,899 participants in India, the most common causes leading to corneal blindness included pterygium (34.5 percent), ocular trauma (22.3 percent), and infectious keratitis (14.9 percent).11 Infectious, traumatic, and autoimmune corneal diseases were the three leading causes of corneal blindness in China.12 A study from Tanzania reported corneal infections, vitamin A deficiency, and measles as the top three causes of bilateral corneal blindness.13

The transplant team with a pre-corneal transplant patient. From left: Dr. Jain; the first corneal transplant recipient in Guyana; Drs. Jindal, Waller, and Patel; and Mr. Subraj.

The transplant team with a pre-corneal transplant patient. From left: Dr. Jain; the first corneal transplant recipient in Guyana; Drs. Jindal, Waller, and Patel; and Mr. Subraj.

In South America, common causes leading to blindness include pterygium, ocular trauma, and trachoma, among others. Ocular trauma constituted 30 percent to 40 percent of all ophthalmological emergencies. Trachoma is another condition that leads to corneal blindness. Some reports from Latin America cite relatively small numbers of infections, which may indicate the problem is being underdiagnosed.14 In Mexico, a report from 2007 showed up to 42 percent of children in certain locations are affected by the condition.15 In Brazil, prevalence varied from 2.2 percent in major cities to 50 percent in remote areas, although more recent reports suggest decreasing prevalence.16-18

Eye bank requirements and procedures

The key to any successful transplant program is rigorous organ banking. Eye banks in the U.S. must be certified by the Eye Bank Association of America (EBAA), which was established in 1961 to serve as the national accrediting organization for eye banks in the U.S., and the U.S. Food and Drug Administration. Eye banks in Central and South America, as well as the Caribbean, should be certified by the Pan American Association of Eye Banks, also known as Associação Pan-Americana de Bancos de Olhos (APABO).

Essential resources for corneal transplants

  • Documentation of cleanliness
  • Access to sterile surgical instrument packs, gloves, gown, mask
  • Sufficient outlets and back-up power
  • Solutions: Sterile saline for irrigation
  • Recording refrigerator: 24/7/365, 2–8o C
  • Sink, counter space, laminar flow hood, access to slit lamp biomicroscope
  • Endothelial cell counter
  • Tissue: Labeled and segregated into four distinct and separate groups: in process, quarantine, research, ready for release
  • Optisol GS or McCarey-Kaufman medium (the two types of storage media for the harvested cornea that include gentamicin and streptomycin)
  • Penlight, slit lamp, specular microscope, optical coherence tomography to evaluate the eye
  • Trephines, trephine handle, donor corneal punch

To attain certification, eye banks must have a medical director—an ophthalmologist with expertise in cornea transplantation—and an administrative director on staff. The medical director is responsible for ensuring the application of medical standards to all aspects of the system, educating health care personnel, releasing and distributing corneal tissue, and overseeing the waiting list. The administrative director, on the other hand, is responsible for public awareness and quality control and interacts with accreditation agencies, including the APABO, the ministry of health in the host nation, and the national association of ophthalmology.

Eye bank staff also must include at least one technician who is certified by APABO. The technician’s responsibilities include obtaining the consent of the family for corneal donation, conducting a medical history review, examining the donor, evaluating the eye and determining appropriateness of tissue for transplantation, retrieving tissue by following eye bank standard operating procedures (SOPs), and obtaining serologic testing of the donor. The essential materials needed for a bank to operate appropriately are described in the sidebar.

To operate an independent eye bank, SOPs, including medical standards to protect the tissue recipient and the technician, must be established and followed. Processes related to uniform evaluation procedures, recipient and donor data collection, quality assurance procedures, outcome analysis, and accountability should also be established. The technician must follow SOPs regarding consent of the family for corneal donation; obtaining medical history in a uniform manner; and ensuring that there are no specific contraindications for donation, such as positive human immunodeficiency virus status, hepatitis status, or an injectable drug abuser profile. The technician should also rule out active infection of the eye. Other SOPs cover the acquisition of tissue and serologic testing. The medical director oversees all these tasks performed by the technician and ensures an equitable system for the transplant waiting list, with priority given to younger patients and individuals with bilateral blindness.

Factors for success

Corneal transplantation is one of the most successfully performed tissue transplant procedures. The unique properties of corneal transplants have been previously described in the medical literature.19 Specifically, research suggests that corneal transplantation success rates have been associated with the immune privilege status of the avascular cornea. Disparity between recipient and donor at the major histocompatibility complex (HLA) is the predominant reason for allograft rejection and the need for immunosuppressive therapy in other transplanted tissues. For corneal transplantation, however, a large, multicenter study showed that neither HLA-A, -B, nor HLA-DR antigen matching reduced corneal graft failure and ABO blood group matching was also insufficient to reduce the risk of graft failure.20

Recipients of corneal transplant typically require shorter hospital stays (in some cases, just two hours), incur lower hospital charges, and often need only topical immunosuppressive therapy.21 In addition, compared with other transplants in which donor age may play a role, multi-center trials have shown that donor age was unimportant in corneal transplant patients younger than age 75, as long as the endothelial cell count was satisfactory.22

Estimated average cost per patient of corneal transplantation in the U.S. is approximately $16,500.23 In other countries, the cost of corneal transplant ranges from $1,300 to $14,807. Table 1 compares costs of corneal transplant in different countries.23-37

Table 1. Costs of corneal transplant in developing and developed countries

Country Cost*
U.S. $16,500
Guyana Subsidized by our sponsor
Netherlands $7,942–$14,807
Canada $3,171
Singapore $3,710
South Africa $1,300
India $2,100–$2,300
Spain $5,650
Turkey $8,640

*Costs are estimates based on conversions from native currencies to U.S. dollars, and may have changed since the data was initially published.

Availability of corneas in the U.S.

The number of cornea donations in the U.S. is increasing. A 2013 report from 76 domestic and 10 international eye banks cited 72,736 total corneal grafts—a 5.9 percent increase from the previous year. According to the EBAA, 48,229 corneal transplants were performed during 2013 in the U.S., and 29,646 corneas were obtained from donor registries in 2013.32 The success of eye banks in the U.S. is largely attributed to public awareness regarding organ donation.

Due to the EBAA’s efficient framework described previously and to high rates of eye donation, the U.S. has sufficient quantities to both meet domestic demands and provide tissue to international recipients.33 A similar program in the developing world is the National Eye Bank of Sri Lanka, which has emerged as an exemplar of corneal donation and international export of corneas in Asia and serves as a role model for developing countries.34

The EBAA authorizes each eye bank to be responsible for distribution of tissue using a list of professionals and institutions approved to receive ocular tissue. If complications occur, such as rejection of the cornea, the transplant surgeon must notify all eye banks involved in the recovery, processing, storage, final distribution, tissue evaluation, and donor eligibility determination. It is expected that the transplant surgeon will notify the eye bank of surgical complications and one-year follow-up even if the corneal transplant is done in another country. However, disposal of corneas in excess of demand depends on the individual eye bank and on the relationship established between them and the U.S. or foreign corneal transplant surgeons.

PPP model at work

Humanitarian missions are essential to meet the need for sight restoration in developing countries, and several organizations in the U.S. support the growth of eye banks around the developing world. There are variations on our model of PPP that include training of local surgeons and funding from private sources in the U.S. or internationally. In 2013, for example, the Lions Eye Bank of Delaware Valley, Philadelphia, PA, provided corneas to transplant surgeons for a mission in Kenya.35 The San Diego Eye Bank, CA, is involved in the International Cornea Project, which is responsible for missions to provide corneas for transplantation around the world.36 Another example is the Cornea Research Foundation, which sponsored a surgeon to teach advanced surgical techniques to Nepali surgeons.37

Dr. Waller (right) and a local physician examine a patient before surgery.

Dr. Waller (right) and a local physician examine a patient before surgery.

At the beginning of 2014, we realized that there was an acute need in Guyana for subspecialty surgical services, in addition to kidney transplantation. We took an incremental approach by reviewing the need for corneal transplantation. This analysis was subjective, as Guyana has no centralized registry for eye diseases. On the first visit, Dr. Waller discussed eye banking and transplantation with Guyanese ophthalmologists and screened 20 patients, eight of whom were suitable candidates for corneal transplants; the transplants were subsequently performed for six patients. Dr. Waller joined the team on its 19th visit and performed the corneal transplants during the 20th visit. Other members of the team continued their work with kidney transplantation and related procedures during these visits.

The six successful corneal transplants were performed within a week by the Guyanese surgeon under the supervision of Dr. Waller. Donor age ranged from 26 to 75 years old (mean 63 years). Endothelial cell count ranged between 2,101 and 3,195 cells/mm2 (mean 2,509 cells/mm2). Recipient age ranged from 20 to 72 years (mean 39 years). Most (83.3 percent) of the recipient population were male. The diagnosis leading to corneal blindness included keratoconus with apical scar (three patients), pseudophakic bullous keratopathy (one patient), leucomatous corneal opacity (one patient), and trauma (one patient). The operation performed on all patients was penetrating keratoplasty. All patients had improvement in their vision postoperatively (see Table 2). No complications were noted, except in the case of the patient with traumatic eye injury, who experienced mild epithelial haze at six months’ follow-up.

Table 2. Recipient information

Recipient Age (years) and sex* Diagnosis Procedure Previous visual acuity Postoperative corrected visual acuity Complications

1

22 F

Keratoconus with apical scar Penetrating keratoplasty

6/24

6/9 (pinhole)

N/A

2

20 M

Keratoconus with apical scar Penetrating keratoplasty

1/60

6/9

N/A

3

48 M

Pseudophakic bullous keratopathy Penetrating keratoplasty

HM

6/9

N/A

4

36 M

Leucomatous corneal opacity Penetrating keratoplasty

HM

6/6

N/A

5

72 M

Post bee sting corneal decompensation Penetrating keratoplasty with cataract extraction with intraocular lens implant

HM

6/36

Mild sub-epithelialhaze with high astigmatism

6

36 M

Keratoconus with apical scar Penetrating keratoplasty

4/60

6/9

N/A

*F-Female, M-Male; Penetrating keratoplasty with cataract extraction with intraocular lens implant; Hand motions close to face.

Dr. Stephen Guy (left) and Dr. Jindal discuss ultrasound findings on a kidney transplant patient. The local Guyanese radiologist (right) is Dr. Panchal.

Dr. Stephen Guy (left) and Dr. Jindal discuss ultrasound findings on a kidney transplant patient. The local Guyanese radiologist (right) is Dr. Panchal.

Our work was made possible because of an intricate partnership between the private and public sectors. In a developing country like Guyana, few patients could afford the cost of corneal transplantation. The Guyanese government plays a significant role in facilitating physician licenses and liability coverage, and importing generic medications, free of charge to the patients, while local medical staff identifies patients and provides pre- and postoperative care under the supervision of Dr. Waller in case of corneal transplants and Dr. Jindal in case of kidney transplants. Our team continues to advise Guyanese physicians via e-mails/Skype and telephone calls on postoperative care.

Ensuring sustainability

Conventionally, limited tissue availability and a lack of trained personnel have made corneal transplants in developing countries unaffordable and inaccessible. A sustainable corneal transplant capacity in a developing country requires skilled local surgeons, and our team engaged in teaching and supervising local surgeons. We also are working with the government of Guyana to establish an eye bank based on U.S. standards.

In addition, a waiting list is being generated so that corneas can be optimally allocated for transplantation. Two corneas that our team brought to Guyana from the U.S. went unused as one patient who was screened in the initial visit declined surgery, and the other procedure was canceled because of the patient’s uncontrolled diabetes. Care will be taken to avoid these situations in the future by creating a larger waiting list of suitable patients and by ensuring that local eye surgeons examine transplant candidates at regular intervals to verify suitability for transplantation. At press time, the U.S. team’s next visit was scheduled to take place in April 2015.

Patients, the government of Guyana, and the media appreciate that U.S. surgeons have undertaken a complex surgical procedure using corneas donated by U.S. patients as illustrated by positive reports in the Guyanese press.24,25 Ultimately, we strive to ensure that corneal transplants in Guyana involve appropriate and equitable patient selection, well-trained and informed surgeons, and meticulous follow-up care.

Acknowledgements

The authors would like to acknowledge the contributions made by the following individuals to both this article and the corneal transplant program: George Subraj, philanthropist and president, Zara Realty, Queens, NY, who funded the program; the Government of Guyana for providing the use of facilities and medications; the staff of Balwant Singh’s Hospital, Georgetown, Guyana, where the transplants were performed; and Neeraj Jain, MD, eye surgeon at Balwant Singh’s Hospital, for compiling the waiting list, follow-up data, and performing the corneal transplants under the supervision of Dr. Waller.

Disclaimer

The views expressed in this article are those of the authors and do not reflect the official policy of the U.S. Department of the Army, the U.S. Department of Defense, or the U.S. government. No financial conflict of interest exists.


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