Abstract
Purpose: :
To evaluate the sustainability of the Boston Keratoprosthesis (KPro) in Africa.
Methods: :
Through an international collaboration between Mass. Eye and Ear Infirmary (MEEI), Boston, MA, USA and two hospitals in Africa (Menelick II, Ethiopia and Makkay Eye Complex, Sudan), a longitudinal multicenter prospective sustainability trial was developed. A total of 83 patients were screened in both Ethiopia and Sudan. Only 26 patients satisfied our inclusion criteria based on approved FDA and clinical standards for KPro implantation. Patients were followed for 2 years, locally by attending physicians and remotely by MEEI surgeons and researchers. Outcome measures included: anatomical retention, infection rate, complication rate, cost-utility analysis (CUA), and quality of life parameters. Univariate and multivariate sensitivity analyses were designed to assist extrapolative and generalizability projections. Results were compared to outcomes data in the USA.
Results: :
Patients presented with severe corneal disease -- including repeat graft failure, trachoma, measles keratitis, and Mooren's ulcer. Anatomic retention was maintained in 23 of 26 patients (88%). In 5 cases, infections, of various etiologies, were reported and treated successfully in 3 instances. In 2 cases in Sudan, presumptive endophthalmitis occurred within the first postoperative week. A total of 4 eyes received KPro implantation with ipsilateral autologous corneas. Patient vision improved, on average, from HM to 20/100. CUA suggested superior cost-effectiveness compared to US figures of 16,140 $/QALY. Patient quality of life and satisfaction improved in 100% of cases.
Conclusions: :
The results are encouraging, indicating that the Boston KPro may be a sustainable device in the non-industrialized world for reducing the burden of severe corneal disease and blindness. Despite this optimism, complications do occur with often devastating consequences. Furthermore, cost-effectiveness is relative, and despite our findings, and the high inherent utility of the device, it will undoubtedly continue to be economically difficult on this population.
Keywords: keratoprostheses • cornea: clinical science • clinical (human) or epidemiologic studies: health care delivery/economics/manpower