Artificial corneas versus donor corneas for repeat corneal transplants.

BACKGROUND Individuals who have failed one or more full thickness penetrating keratoplasties (PKs) may be offered repeat corneal surgery using an artificial or donor cornea. An artificial or prosthetic cornea is known as a keratoprosthesis. Both donor and artificial corneal transplantations involve removal of the diseased and opaque recipient cornea (or the previously failed cornea) and replacement with another donor or prosthetic cornea. OBJECTIVES To assess the effectiveness of artificial versus donor corneas in individuals who have had one or more failed donor corneal transplantations. SEARCH METHODS We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2013, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2013), EMBASE (January 1980 to November 2013), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to November 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 27 November 2013. SELECTION CRITERIA Two review authors independently assessed reports from the electronic searches to identify randomized controlled trials (RCTs) or controlled clinical trials (CCTs). We resolved discrepancies by discussion or consultation with a third review author. DATA COLLECTION AND ANALYSIS For discussion purposes, we assessed findings from observational cohort studies and non-comparative case series. No data synthesis was performed. MAIN RESULTS We did not identify any RCTs or CCTs comparing artificial corneas with donor corneas for repeat corneal transplantations. AUTHORS' CONCLUSIONS The optimal management for those individuals who have failed a conventional corneal transplantation is not known. Currently, in some centers, artificial corneal devices routinely are recommended after just one graft failure, and in others, not until after multiple graft failures, or not at all. To date, there have been no controlled trials comparing the visual outcomes and complications of artificial corneal devices (particularly the Boston type 1 keratoprosthesis which is the most commonly implanted artificial corneal device) with repeat donor corneal transplantation, in order to guide surgeons and their patients. It is apparent that such a trial is needed and would offer significant benefit to an ever-increasing pool of people with visual disability due to corneal opacification, most of whom are still in productive stages of their lives.

[1]  D. Pavan-Langston,et al.  The Boston keratoprosthesis in herpetic keratitis. , 2007, Archives of ophthalmology.

[2]  Gregory J. McCormick,et al.  Keratoprosthesis: the Dohlman-Doane device. , 2005, American journal of ophthalmology.

[3]  E. Cohen,et al.  Third or Greater Penetrating Keratoplasties: Indications, Survival, and Visual Outcomes , 2010, Cornea.

[4]  D. Coster,et al.  How successful is corneal transplantation? A report from the Australian corneal graft register , 1995, Eye.

[5]  M. Harissi-Dagher,et al.  Boston type 1 keratoprosthesis: the CHUM experience. , 2011, Canadian journal of ophthalmology. Journal canadien d'ophtalmologie.

[6]  S. Schwartz,et al.  POSTOPERATIVE POSTERIOR SEGMENT COMPLICATIONS IN EYES TREATED WITH THE BOSTON TYPE I KERATOPROSTHESIS , 2013, Retina.

[7]  M. Harissi-Dagher,et al.  Prevalence, progression, and impact of glaucoma on vision after Boston type 1 keratoprosthesis surgery. , 2012, American journal of ophthalmology.

[8]  M. Doane,et al.  Keratoprosthesis: Preoperative Prognostic Categories , 2001, Cornea.

[9]  K. Ruprecht,et al.  Medium term results in keratoprostheses with biocompatible and biological haptic , 2006, Graefe's Archive for Clinical and Experimental Ophthalmology.

[10]  M. Srinivasan,et al.  Corneal blindness: a global perspective. , 2001, Bulletin of the World Health Organization.

[11]  J. Graney,et al.  Repeat Penetrating Keratoplasty versus the Boston Keratoprosthesis in Graft Failure , 2005, International ophthalmology clinics.

[12]  Elham R. Al-Tamimi,et al.  Indications and techniques employed for keratoplasty in the Eastern province of Saudi Arabia: 6 years of experience , 2015, Annals of Saudi medicine.

[13]  F. Matonti,et al.  La kératoprothèse Alphacor™ : dispositif, technique chirurgicale et résultats cliniques , 2013 .

[14]  F. Yu,et al.  The Boston type I keratoprosthesis: improving outcomes and expanding indications. , 2009, Ophthalmology.

[15]  E. Cohen,et al.  Boston Keratoprosthesis Outcomes and Complications , 2009, Cornea.

[16]  P. Rozsival,et al.  AlphaCor artificial cornea: clinical outcome , 2011, Eye.

[17]  R. Michael,et al.  Long-term functional and anatomical results of osteo- and osteoodonto-keratoprosthesis , 2008, Graefe's Archive for Clinical and Experimental Ophthalmology.

[18]  J. Stein,et al.  Glaucoma Associated With Boston Type I Keratoprosthesis , 2012, Cornea.

[19]  J. Güell,et al.  Outcomes with the Boston Type 1 Keratoprosthesis at Instituto de Microcirugía Ocular IMO. , 2011, Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society.

[20]  Robert W. Thompson,et al.  Long-term graft survival after penetrating keratoplasty. , 2003, Ophthalmology.

[21]  K. Biernacki,et al.  Boston Keratoprosthesis Type 1 Surgery: Use of Frozen Versus Fresh Corneal Donor Carriers , 2012, Cornea.

[22]  M. Harissi-Dagher,et al.  The Boston Keratoprosthesis in severe ocular trauma. , 2007, Canadian journal of ophthalmology. Journal canadien d'ophtalmologie.

[23]  C. A. Utine,et al.  Visual and clinical outcomes of explantation versus preservation of the intraocular lens during keratoprosthesis implantation , 2011, Journal of cataract and refractive surgery.

[24]  D. Coster,et al.  Risk Factors for Human Corneal Graft Failure Within the Australian Corneal Graft Registry , 2008, Transplantation.

[25]  T. Neuhann,et al.  Ergebnisse nach Boston-Keratoprothese , 2012, Der Ophthalmologe.

[26]  F. Yu,et al.  Microbial keratitis after Boston type I keratoprosthesis implantation: incidence, organisms, risk factors, and outcomes. , 2013, Ophthalmology.

[27]  M. Wagoner,et al.  Outcome of Primary Adult Penetrating Keratoplasty in a Saudi Arabian Population , 2009, Cornea.

[28]  M. Durand,et al.  Endophthalmitis after keratoprosthesis: incidence, bacterial causes, and risk factors. , 2001, Archives of ophthalmology.

[29]  J. Güell,et al.  The Boston Type I keratoprosthesis: an assessment of its efficacy and safety. , 2011, Ophthalmic surgery, lasers & imaging : the official journal of the International Society for Imaging in the Eye.

[30]  Dennis E. Cortés,et al.  High-Resolution Spectral Domain Anterior Segment Optical Coherence Tomography in Type 1 Boston Keratoprosthesis , 2013, Cornea.

[31]  J. Chodosh,et al.  Titanium back plate for a PMMA keratoprosthesis: clinical outcomes , 2011, Graefe's Archive for Clinical and Experimental Ophthalmology.

[32]  D. Ritterband,et al.  Boston type 1 keratoprosthesis: the New York Eye and Ear experience , 2012, Eye.

[33]  F. Yu,et al.  The Boston Keratoprosthesis in the Management of Corneal Limbal Stem Cell Deficiency , 2011, Cornea.

[34]  D. Coster,et al.  The Australian Corneal Graft Registry. 1990 to 1992 report. , 1993, Australian and New Zealand journal of ophthalmology.

[35]  J. Chodosh,et al.  Cost-effectiveness of the Boston keratoprosthesis. , 2010, American journal of ophthalmology.

[36]  Claes H Dohlman,et al.  Importance of Nutrition to Corneal Grafts When Used as a Carrier of the Boston Keratoprosthesis , 2007, Cornea.

[37]  I J Constable,et al.  Corneal replacement using a synthetic hydrogel cornea, AlphaCor™: device, preliminary outcomes and complications , 2003, Eye.

[38]  I. Constable,et al.  The Chirila Keratoprosthesis: phase I human clinical trial. , 2002, Ophthalmology.

[39]  Jonathan J Deeks,et al.  Chapter 13: Including non-randomized studies , 2008 .

[40]  Ying Qian,et al.  Keratoprosthesis: Current Techniques , 2006, Cornea.

[41]  Sueko M Ng,et al.  Boston Type 1 Keratoprosthesis versus Repeat Donor Keratoplasty for Corneal Graft Failure: A Systematic Review and Meta-analysis. , 2016, Ophthalmology.

[42]  D. Tan,et al.  Outcomes of Implantation of an Artificial Cornea, AlphaCor: Effects of Prior Ocular Herpes Simplex Infection , 2002, Cornea.

[43]  F. Yu,et al.  International results with the Boston type I keratoprosthesis. , 2012, Ophthalmology.

[44]  M. Mannis,et al.  Longer-term vision outcomes and complications with the Boston type 1 keratoprosthesis at the University of California, Davis. , 2011, Ophthalmology.

[45]  W. Shihadeh,et al.  Outcomes of the Boston Keratoprosthesis in Jordan , 2012, Middle East African journal of ophthalmology.

[46]  Michael W. Belin,et al.  Retention of the Boston keratoprosthesis type 1: multicenter study results. , 2013, Ophthalmology.

[47]  A. Karkhaneh,et al.  Fyodorov–Zuev keratoprosthesis implantation: long-term results in patients with multiple failed corneal grafts , 2010, Graefe's Archive for Clinical and Experimental Ophthalmology.

[48]  A. Foster,et al.  Prevalence, incidence and distribution of visual impairment , 2003 .

[49]  E. Akpek,et al.  Current concepts and techniques in keratoprosthesis , 2005, Current opinion in ophthalmology.

[50]  I. Constable,et al.  A Risk Score as Part of an Evidence-Based Approach to the Selection of Corneal Replacement Surgery , 2005, Cornea.

[51]  I. Schwab,et al.  Boston Type 1 Keratoprosthesis: The University of California Davis Experience , 2009, Cornea.

[52]  M. Belin,et al.  Risk factors for the development of retroprosthetic membranes with Boston keratoprosthesis type 1: multicenter study results. , 2012, Ophthalmology.

[53]  R. Pineda,et al.  Outcomes of Boston keratoprosthesis in aniridia: a retrospective multicenter study. , 2007, American journal of ophthalmology.

[54]  U. Rehany,et al.  The profile of repeated corneal transplantation. , 2001, Ophthalmology.

[55]  D. Altman,et al.  Chapter 8: Assessing risk of bias in included studies , 2008 .

[56]  Nikolaos S. Tsiklis,et al.  Changing Indications for Penetrating Keratoplasty in Greece, 1982–2006: A Multicenter Study , 2010, Cornea.

[57]  Rony R. Sayegh,et al.  The Boston keratoprosthesis in Stevens-Johnson syndrome. , 2008, American journal of ophthalmology.

[58]  Celia R Hicks,et al.  AlphaCor: Clinical Outcomes , 2006, Cornea.

[59]  E. Myrowitz,et al.  Short-term visual outcomes of Boston type 1 keratoprosthesis implantation. , 2010, Ophthalmology.

[60]  M. Belin,et al.  Results from the multicenter Boston Type 1 Keratoprosthesis Study. , 2006, Ophthalmology.