12/3/2016 Disclosure Anthony J. Aldave, M.D. Options and Outcomes in the •Consultant (ad hoc) Management of Corneal Limbal Stem • 5AM Ventures Cell Deficiency • Avellino Laboratories • W. L. Gore & Associates The University of California, San Francisco • Noveome Biotherapeutics (Stemnion) Ophthalmology Update 2016 • Sun Ophthalmics San Francisco, CA •Research Funding December 2-3, 2016 • National Eye Institute Anthony J. Aldave, M.D. •Speaker’s Bureau Professor of Ophthalmology Chief, Cornea and Uveitis Division • Avellino Laboratories The Jules Stein Eye Institute The University of California, Los Angeles Management of Bilateral LSCD Lecture Outline •Keratolimbal allografts •Oral mucosal epithelial autografts •Keratoprostheses 1
12/3/2016 Management of Bilateral LSCD Lecture Outline •Keratolimbal allografts •Oral mucosal epithelial autografts •Keratoprostheses Management of Bilateral LSCD Management of Bilateral LSCD Keratolimbal Allografts Indications Keratolimbal Allografts Vision •All 26 studies were noncomparative case series •Improvement in CDVA > 2 Snellen lines • 56% (14/25) of eyes 1 • No randomized clinical trials •31% (8/26) of studies surveyed bilateral severe • 67% (10/15) of eyes 2 or total LSCD alone • 81% (13/16) of eyes 3 • Keratolimbal allograft (KLAL) with systemic • 90% (9/10) of eyes 4 immunosuppression in 75% (6/8) • Not specified in 4 of the 8 studies 5 • Chemical or thermal burn (n = 67) 1 Holland EJ. Epithelial transplantation for the management of severe ocular surface disease. Trans Am Ophthalmol Soc. • Aniridia (n = 40) 1996;94:677-743. 2 Inatomi T, Nakamura T, Koizumi N, et al. Midterm results on ocular surface reconstruction using cultivated autologous • Stevens-Johnson syndrome (n = 27) oral mucosal epithelial transplantation. Am J Ophthalmol. 2006 ;141(2):267-275. 3 Tsai RJ, Tseng SC. Human allograft limbal transplantation for corneal surface reconstruction. Cornea. 1994 ;13:389-400. 4 Ivekovic R, Tedeschi-Reiner E, Novak-Laus K, Andrijevic-Derk B, Cima I, Mandic Z. Limbal graft and/or amniotic membrane transplantation in the treatment of ocular burns. Ophthalmologica. 2005;219:297-302. 5 Cauchi PA, Ang GS, Azuara-Blanco A, Burr JM. A systematic literature review of surgical interventions for limbal stem cell Cauchi PA, Ang GS, Azuara-Blanco A, Burr JM. A systematic literature review of surgical deficiency in humans. Am J Ophthalmol. 2008;146:251-259. interventions for limbal stem cell deficiency in humans. Am J Ophthalmol. 2008;146:251-259. 2
12/3/2016 Management of Bilateral LSCD Management of Bilateral LSCD Keratolimbal Allografts Survival Keratolimbal Allografts Survival Solomon A, Ellies P, Anderson DF, Touhami A, Grueterich M, Espana EM, Ti SE, Goto E, Feuer WJ, Tseng SC. Long-term Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface outcome of keratolimbal allograft with or without penetrating keratoplasty for total limbal stem cell deficiency. disorders. Ophthalmology. 2002;109:1278-84. Ophthalmology. 2002;109:1159-66. Management of Bilateral LSCD Keratolimbal Allografts Survival Han ES, Wee WR, Lee JH, Kim MK. Long-term outcome and prognostic factor analysis for keratolimbal allografts. Graefes Arch Clin Exp Ophthalmol. 2011;249:1697-704. 3
12/3/2016 Management of Bilateral LSCD Lecture Outline •Keratolimbal allografts •Oral mucosal epithelial autografts •Keratoprostheses Holland EJ, Mogilishetty G, Skeens HM, Hair DB, Neff KD, Biber JM, Chan CC. Systemic immunosuppression in ocular surface stem cell transplantation: results of a 10-year experience. Cornea. 2012;31(6):655-61. Management of Corneal LSCD Oral Mucosal Epithelial Autograft Nishida K, Yamato M, Hayashida Y, et al. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004;351:1187-96. 4
12/3/2016 Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation. Am J Ophthalmol. 2006;141:267-275. Satake Y, Higa K, Tsubota K, Shimazaki J. Long-term outcome of cultivated oral mucosal epithelial sheet transplantation in treatment of total limbal stem cell deficiency. Ophthalmology. 2011;118: 1524-30. 5
12/3/2016 Management of Bilateral LSCD Lecture Outline •Keratolimbal allografts •Oral mucosal epithelial autografts •Keratoprostheses Management of Bilateral LSCD Management of Bilateral LSCD Boston Keratoprosthesis Indications Boston Keratoprosthesis Visual Acuity 68 of 173 Procedures SJS 6% 4% Graft failure 27% 7% Chemical injury Corneal scarring/vascularization 13% MMP Aniridia 25% 16% MMC / Topcial medication toxicity Cicatrizing conjunctivitis 6
12/3/2016 Management of LSCD Management of Bilateral LSCD Comparative Visual Outcomes Boston Keratoprosthesis Retention •Keratolimbal allografts 1.0 Cumulative Proportion of Retention • Post-op VA > 20/200 in 44% of eyes 1,2 0.8 •COMET • Pre-op VA > 20/200 in 0% of eyes 0.6 • Post-op VA > 20/200 in 27% of eyes at 3-34 months 3 •Boston keratoprosthesis 0.4 • Pre-op VA > 20/200 in 7% of eyes 0.2 • Post-op VA > 20/200 in 77%, 88% and 86% of eyes LSCD Non-LSCD at 1, 3 and 5 years 0.0 1. Shi W, Gao H, Wang T, et al. Combined penetrating keratoplasty and keratolimbalallograft transplantation in comparison with corneoscleraltransplantation in the treatment of severe eye burns. Clin Experiment Ophthalmol 2008;36:501–7. 0 24 48 72 96 120 2. Solomon A, Ellies P, Anderson DF, et al. Long-term outcome of keratolimbal allograft with or without penetrating keratoplasty for total limbalstem cell deficiency. Ophthalmology 2002;109:1159–66. Length of Follow-up (Months) 3. Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelialtransplantation. Am J Ophthalmol. 2006;141:267-275. Management of LSCD Management of LSCD Boston Kpro vs KLAL Retention vs Survival Boston Kpro vs KLAL Retention vs Survival 1.0 1.0 Cumulative Proportion of Retention Cumulative Proportion of Retention 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 LSCD LSCD Non-LSCD Non-LSCD 0.0 0.0 0 24 48 72 96 120 0 24 48 72 96 120 Length of Follow-up (Months) Length of Follow-up (Months) Solomon A, Ellies P, Anderson DF, Touhami A, Grueterich M, Espana EM, Ti SE, Goto E, Feuer WJ, Tseng SC. Long-term outcome of keratolimbal allograft with Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface disorders. Ophthalmology. 2002;109:1278-84. or without penetrating keratoplasty for total limbal stem cell deficiency.Ophthalmology. 2002;109:1159-66. 7
12/3/2016 Management of LSCD Management of LSCD Boston Kpro vs KLAL Retention vs Survival Boston Kpro vs COMET Retention vs Survival 1.0 1.0 Cumulative Proportion of Retention Cumulative Proportion of Retention 0.8 0.8 0.6 0.6 0.4 0.4 0.2 0.2 LSCD LSCD Non-LSCD Non-LSCD 0.0 0.0 0 24 48 72 96 120 0 24 48 72 96 120 Length of Follow-up (Months) Length of Follow-up (Months) Han ES, Wee WR, Lee JH, Kim MK. Long-term outcome and prognostic factor analysis for keratolimbal allografts. Graefes Arch Clin Exp Ophthalmol. 2011 Satake Y, Higa K, Tsubota K, Shimazaki J. Long-term outcome of cultivated oral mucosal epithelial sheet transplantation in treatment of total limbal stem cell Nov;249(11):1697-704. deficiency. Ophthalmology. 2011;118: 1524-30. Management of LSCD Management of LSCD Boston Keratoprosthesis Complications Boston Keratoprosthesis Complications 8
12/3/2016 Management of Bilateral LSCD Conclusions Visual Outcomes •Boston keratoprosthesis • Provides superior visual outcomes when compared to the published literature on allogenic keratolimbal and oral mucosal epithelial transplantation Satake Y, Higa K, Tsubota K, Shimazaki J. Long-term outcome of cultivated oral mucosal epithelial sheet transplantation in treatment of total limbal stem cell deficiency. Ophthalmology. 2011;118: 1524-30. Management of Bilateral LSCD Management of Bilateral LSCD Conclusions Retention Conclusions Complications •Boston keratoprosthesis •Boston keratoprosthesis • Retention rate at 5 years is higher than survival rate • Avoids expense and risks associated with systemic of keratolimbal allografts and oral mucosal epithelial immunosuppression autografts • Only complication significantly more common in eyes with LSCD compared to eyes without is persistent epithelial defect 9
12/3/2016 Management of Bilateral LSCD Thank You for Your Attention! Conclusions •aldave@jsei.ucla.edu •The Boston keratoprosthesis is the evidence- based procedure of choice for managing bilateral limbal stem cell deficiency 10
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