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R. Pineda, II, J. D. Ament, Y. Tilahun, I. Behlau, C. H. Dohlman; Prospective Evaluation of Sustaining the Boston Keratoprosthesis in the Developing World: A Pilot Project. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1497.
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To determine whether the Boston Keratoprosthesis (KPro) is a sustainable ophthalmic device in patients in the developing world.
Through an international collaboration between the Massachusetts Eye and Ear Infirmary, Boston, USA and the Menelick II Hospital, Addis Ababa, Ethiopia, six pre-selected patients underwent surgery with the Boston Keratoprosthesis. Lens extraction was performed in patients who were not pseudophakic or aphakic. Patient selection criteria included hospital access, repeated graft failures, binocular blindness, or monocular patients. An International KPro Protocol was developed to standardize pre- and post-operative evaluation and patient education. To reduce costs, the patient’s own cornea was considered as a carrier for the KPro instead of a donor cornea. Locally available chloramphenicol and ciprofloxacin ophthalmic solutions were substituted for the US standards. A monthly drop with 5% povidone-iodine was recommended for broad antimicrobial prophylaxis. Patients were followed monthly to monitor visual acuity, intraocular pressure (IOP), wound integrity, infection and medication compliance.
This pilot study reports seven-month data on six eyes of six Ethiopian patients who received a KPro under local anesthesia. All patients noted improved visual acuity, ranging from hand motion pre-operatively to between CF at 5m and 20/40 post-operatively. All patients were able to self-administer their ophthalmic medications. There were no issues of inflammation, infection, or compliance. One patient had difficulty retaining the BCL and 1 patient developed sterile vitritis and hypotony. Both patients were managed successfully.
Early data indicates that the Boston KPro may be a viable ophthalmic device in the developing world. It remains unclear as to whether KPro may be superior to PK in this setting. Careful patient selection, standardized protocol implementation, and meticulous post-operative follow-up and surveillance are necessary for long-term sustainability. A pilot study in Sudan and additional patients in Ethiopia are being considered for the KPro.
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