Clinical trial NCT01868620 - References

Progressive Keratoconus — Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

Citation(s)

•   Al-Aqaba M, Calienno R, Fares U, Otri AM, Mastropasqua L, Nubile M, Dua HS
  The effect of standard and transepithelial ultraviolet collagen cross-linking on human corneal nerves: an ex vivo study. Am J Ophthalmol. 2012 Feb;153(2):258-266.e2. doi: 10.1016/j.ajo.2011.07.006. Epub 2011 Sep 17.
•   AMSLER M
  [Not Available]. Ophthalmologica. 1946 Feb-Mar;111(2-3):96-101. Undetermined Language.
•   Arne JL, Fournié P
  [Keratoconus, the most common corneal dystrophy. Can keratoplasty be avoided?]. Bull Acad Natl Med. 2011 Jan;195(1):113-29. French.
•   Asri D, Touboul D, Fournié P, Malet F, Garra C, Gallois A, Malecaze F, Colin J
  Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Reference Center for Keratoconus. J Cataract Refract Surg. 2011 Dec;37(12):2137-43. doi: 10.1016/j.jcrs.2011.08.026.
•   Baiocchi S, Mazzotta C, Cerretani D, Caporossi T, Caporossi A
  Corneal crosslinking: riboflavin concentration in corneal stroma exposed with and without epithelium. J Cataract Refract Surg. 2009 May;35(5):893-9. doi: 10.1016/j.jcrs.2009.01.009.
•   Behar-Cohen F, El Aouni A, Le Rouic JF, Parel JM, Renard G, Chauvaud D
  [Iontophoresis: past and future]. J Fr Ophtalmol. 2001 Mar;24(3):319-27. Review. French.
•   Behar-Cohen FF, El Aouni A, Gautier S, David G, Davis J, Chapon P, Parel JM
  Transscleral Coulomb-controlled iontophoresis of methylprednisolone into the rabbit eye: influence of duration of treatment, current intensity and drug concentration on ocular tissue and fluid levels. Exp Eye Res. 2002 Jan;74(1):51-9.
•   Behar-Cohen FF, Parel JM, Pouliquen Y, Thillaye-Goldenberg B, Goureau O, Heydolph S, Courtois Y, De Kozak Y
  Iontophoresis of dexamethasone in the treatment of endotoxin-induced-uveitis in rats. Exp Eye Res. 1997 Oct;65(4):533-45.
•   Borderie VM, Boëlle PY, Touzeau O, Allouch C, Boutboul S, Laroche L
  Predicted long-term outcome of corneal transplantation. Ophthalmology. 2009 Dec;116(12):2354-60. doi: 10.1016/j.ophtha.2009.05.009. Epub 2009 Oct 7.
•   Boxer Wachler BS, Pinelli R, Ertan A, Chan CC
  Safety and efficacy of transepithelial crosslinking (C3-R/CXL). J Cataract Refract Surg. 2010 Jan;36(1):186-8; author reply 188-9. doi: 10.1016/j.jcrs.2009.08.019.
•   Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T
  Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45.
•   Caporossi A, Mazzotta C, Baiocchi S, Caporossi T, Paradiso AL
  Transepithelial corneal collagen crosslinking for keratoconus: qualitative investigation by in vivo HRT II confocal analysis. Eur J Ophthalmol. 2012;22 Suppl 7:S81-8. doi: 10.5301/ejo.5000125.
•   Caporossi A, Mazzotta C, Baiocchi S, Caporossi T
  Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
•   Chauvaud D, Behar-Cohen F, Parel JM, Renard G
  Transscleral iontophoresis of corticosteroids: Phase II Clinical Trial. ARVO Invest Ophthalmol Vis Sci 2000;41:S79.
•   Cheng YY, Visser N, Schouten JS, Wijdh RJ, Pels E, van Cleynenbreugel H, Eggink CA, Zaal MJ, Rijneveld WJ, Nuijts RM
  Endothelial cell loss and visual outcome of deep anterior lamellar keratoplasty versus penetrating keratoplasty: a randomized multicenter clinical trial. Ophthalmology. 2011 Feb;118(2):302-9. doi: 10.1016/j.ophtha.2010.06.005. Epub 2010 Sep 15.
•   Chien YW, Banga AK
  Iontophoretic (transdermal) delivery of drugs: overview of historical development. J Pharm Sci. 1989 May;78(5):353-4. Review.
•   Cohen AE, Assang C, Patane MA, From S, Korenfeld M; Avion Study Investigators
  Evaluation of dexamethasone phosphate delivered by ocular iontophoresis for treating noninfectious anterior uveitis. Ophthalmology. 2012 Jan;119(1):66-73. doi: 10.1016/j.ophtha.2011.07.006. Epub 2011 Nov 23.
•   Colin J, Malet FJ
  Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. 2007 Jan;33(1):69-74.
•   Costello CT, Jeske AH
  Iontophoresis: applications in transdermal medication delivery. Phys Ther. 1995 Jun;75(6):554-63. Review.
•   Dhawan S, Rao K, Natrajan S
  Complications of corneal collagen cross-linking. J Ophthalmol. 2011;2011:869015. doi: 10.1155/2011/869015. Epub 2011 Dec 27.
•   Eljarrat-Binstock E, Orucov F, Frucht-Pery J, Pe'er J, Domb AJ
  Methylprednisolone delivery to the back of the eye using hydrogel iontophoresis. J Ocul Pharmacol Ther. 2008 Jun;24(3):344-50. doi: 10.1089/jop.2007.0097.
•   Epstein RJ, Seedor JA, Dreizen NG, Stulting RD, Waring GO 3rd, Wilson LA, Cavanagh HD
  Penetrating keratoplasty for herpes simplex keratitis and keratoconus. Allograft rejection and survival. Ophthalmology. 1987 Aug;94(8):935-44.
•   Ertan A, Kamburoglu G
  Intacs implantation using a femtosecond laser for management of keratoconus: Comparison of 306 cases in different stages. J Cataract Refract Surg. 2008 Sep;34(9):1521-6. doi: 10.1016/j.jcrs.2008.05.028.
•   Ferrara G, Torquetti L, Ferrara P, Merayo-Lloves J
  Intrastromal corneal ring segments: visual outcomes from a large case series. Clin Exp Ophthalmol. 2012 Jul;40(5):433-9. doi: 10.1111/j.1442-9071.2011.02698.x.
•   Filippello M, Stagni E, O'Brart D
  Transepithelial corneal collagen crosslinking: bilateral study. J Cataract Refract Surg. 2012 Feb;38(2):283-91. doi: 10.1016/j.jcrs.2011.08.030. Epub 2011 Nov 21. Erratum in: J Cataract Refract Surg. 2012 Aug;38(8):1515.
•   Ghanem RC, Netto MV, Ghanem VC, Santhiago MR, Wilson SE
  Peripheral sterile corneal ring infiltrate after riboflavin-UVA collagen cross-linking in keratoconus. Cornea. 2012 Jun;31(6):702-5. doi: 10.1097/ICO.0b013e318226da53.
•   Ghanem VC, Ghanem RC, de Oliveira R
  Postoperative pain after corneal collagen cross-linking. Cornea. 2013 Jan;32(1):20-4. doi: 10.1097/ICO.0b013e31824d6fe3.
•   Greenstein SA, Fry KL, Bhatt J, Hersh PS
  Natural history of corneal haze after collagen crosslinking for keratoconus and corneal ectasia: Scheimpflug and biomicroscopic analysis. J Cataract Refract Surg. 2010 Dec;36(12):2105-14. doi: 10.1016/j.jcrs.2010.06.067.
•   Horwath-Winter J, Schmut O, Haller-Schober EM, Gruber A, Rieger G
  Iodide iontophoresis as a treatment for dry eye syndrome. Br J Ophthalmol. 2005 Jan;89(1):40-4.
•   Hughes L, Maurice DM
  A fresh look at iontophoresis. Arch Ophthalmol. 1984 Dec;102(12):1825-9.
•   Jones RF, Maurice DM
  New methods of measuring the rate of aqueous flow in man with fluorescein. Exp Eye Res. 1966 Jul;5(3):208-20.
•   Kennedy RH, Bourne WM, Dyer JA
  A 48-year clinical and epidemiologic study of keratoconus. Am J Ophthalmol. 1986 Mar 15;101(3):267-73.
•   Kirkness CM, Ficker LA, Steele AD, Rice NS
  The success of penetrating keratoplasty for keratoconus. Eye (Lond). 1990;4 ( Pt 5):673-88.
•   Koller T, Mrochen M, Seiler T
  Complication and failure rates after corneal crosslinking. J Cataract Refract Surg. 2009 Aug;35(8):1358-62. doi: 10.1016/j.jcrs.2009.03.035.
•   Koppen C, Wouters K, Mathysen D, Rozema J, Tassignon MJ
  Refractive and topographic results of benzalkonium chloride-assisted transepithelial crosslinking. J Cataract Refract Surg. 2012 Jun;38(6):1000-5. doi: 10.1016/j.jcrs.2012.01.024.
•   Krachmer JH, Feder RS, Belin MW
  Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. Review.
•   Krumeich JH, Daniel J, Knülle A
  Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998 Apr;24(4):456-63.
•   Kymionis GD, Portaliou DM, Bouzoukis DI, Suh LH, Pallikaris AI, Markomanolakis M, Yoo SH
  Herpetic keratitis with iritis after corneal crosslinking with riboflavin and ultraviolet A for keratoconus. J Cataract Refract Surg. 2007 Nov;33(11):1982-4.
•   Kymionis GD, Portaliou DM, Diakonis VF, Kounis GA, Panagopoulou SI, Grentzelos MA
  Corneal collagen cross-linking with riboflavin and ultraviolet-A irradiation in patients with thin corneas. Am J Ophthalmol. 2012 Jan;153(1):24-8. doi: 10.1016/j.ajo.2011.05.036. Epub 2011 Sep 8.
•   Kymionis GD, Portaliou DM, Pallikaris IG
  Additional complications of corneal crosslinking. J Cataract Refract Surg. 2010 Jan;36(1):185; author reply 186. doi: 10.1016/j.jcrs.2009.07.028.
•   Labiris G, Kaloghianni E, Koukoula S, Zissimopoulos A, Kozobolis VP
  Corneal melting after collagen cross-linking for keratoconus: a case report. J Med Case Rep. 2011 Apr 16;5:152. doi: 10.1186/1752-1947-5-152.
•   Lam TT, Edward DP, Zhu XA, Tso MO
  Transscleral iontophoresis of dexamethasone. Arch Ophthalmol. 1989 Sep;107(9):1368-71.
•   Leccisotti A, Islam T
  Transepithelial corneal collagen cross-linking in keratoconus. J Refract Surg. 2010 Dec;26(12):942-8. doi: 10.3928/1081597X-20100212-09. Epub 2010 Feb 15.
•   Lim LS, Beuerman R, Lim L, Tan DT
  Late-onset deep stromal scarring after riboflavin-UV-A corneal collagen cross-linking for mild keratoconus. Arch Ophthalmol. 2011 Mar;129(3):360-2. doi: 10.1001/archophthalmol.2011.23.
•   Mazzotta C, Balestrazzi A, Baiocchi S, Traversi C, Caporossi A
  Stromal haze after combined riboflavin-UVA corneal collagen cross-linking in keratoconus: in vivo confocal microscopic evaluation. Clin Exp Ophthalmol. 2007 Aug;35(6):580-2.
•   McMahon TT, Edrington TB, Szczotka-Flynn L, Olafsson HE, Davis LJ, Schechtman KB; CLEK Study Group
  Longitudinal changes in corneal curvature in keratoconus. Cornea. 2006 Apr;25(3):296-305.
•   Parkinson TM, Ferguson E, Febbraro S, Bakhtyari A, King M, Mundasad M
  Tolerance of ocular iontophoresis in healthy volunteers. J Ocul Pharmacol Ther. 2003 Apr;19(2):145-51.
•   Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW 3rd
  Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial. Clin Ophthalmol. 2011;5:633-43. doi: 10.2147/OPTH.S19349. Epub 2011 May 15.
•   Pollhammer M, Cursiefen C
  Bacterial keratitis early after corneal crosslinking with riboflavin and ultraviolet-A. J Cataract Refract Surg. 2009 Mar;35(3):588-9. doi: 10.1016/j.jcrs.2008.09.029.
•   Rabinowitz YS, Nesburn AB, McDonnell PJ
  Videokeratography of the fellow eye in unilateral keratoconus. Ophthalmology. 1993 Feb;100(2):181-6.
•   Rabinowitz YS
  Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. Review.
•   Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE
  Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
•   Rama P, Di Matteo F, Matuska S, Paganoni G, Spinelli A
  Acanthamoeba keratitis with perforation after corneal crosslinking and bandage contact lens use. J Cataract Refract Surg. 2009 Apr;35(4):788-91. doi: 10.1016/j.jcrs.2008.09.035.
•   Reinhart WJ, Musch DC, Jacobs DS, Lee WB, Kaufman SC, Shtein RM
  Deep anterior lamellar keratoplasty as an alternative to penetrating keratoplasty a report by the american academy of ophthalmology. Ophthalmology. 2011 Jan;118(1):209-18. doi: 10.1016/j.ophtha.2010.11.002. Review.
•   Rodríguez-Ausín P, Gutiérrez-Ortega R, Arance-Gil A, Romero-Jimenez M, Fuentes-Páez G
  Keratopathy after cross-linking for keratoconus. Cornea. 2011 Sep;30(9):1051-3. doi: 10.1097/ICO.0b013e3182096789.
•   Savoldelli M, Parel JM, D'Hermie F, Kasner L, Pouliquen Y, de Kozak Y, Behar-Cohen F
  An histologic and ultrastructural study of the rat and the rabbit eye after iontophoresis. ARVO. Invest Ophthalmol Vis Sci 1998;39:S927.
•   Spoerl E, Hoyer A, Pillunat LE, Raiskup F
  Corneal cross-linking and safety issues. Open Ophthalmol J. 2011 Feb 11;5:14-6. doi: 10.2174/1874364101105010014.
•   Spoerl E, Huhle M, Seiler T
  Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103.
•   Spoerl E, Seiler T
  Techniques for stiffening the cornea. J Refract Surg. 1999 Nov-Dec;15(6):711-3.
•   The Australian Corneal Graft Registry
  1990 to 1992 report. Aust N Z J Ophthalmol. 1993 May;21(2 Suppl):1-48. Review.
•   Touboul D, Robinet-Perrin A, Fournié P, Malecaze F
  [Efficacy of corneal cross-linking for the treatment of keratoconus]. J Fr Ophtalmol. 2016 Mar;39(3):308-14. doi: 10.1016/j.jfo.2015.12.002. Epub 2016 Mar 16. Review. French.
•   Vimalin J, Gupta N, Jambulingam M, Padmanabhan P, Madhavan HN
  The effect of riboflavin-UV-A treatment on corneal limbal epithelial cells--a study on human cadaver eyes. Cornea. 2012 Sep;31(9):1052-9. doi: 10.1097/ICO.0b013e3182498902.
•   Vinciguerra P, Albè E, Romano MR, Sabato L, Trazza S
  Stromal opacity after cross-linking. J Refract Surg. 2012 Mar;28(3):165. doi: 10.3928/1081597X-20120301-04.
•   von Sallmann L
  Iontophoretic introduction of atropine and scopolamine into the rabbit eye. Arch Ophthalmol 1943;29:711-9.
•   Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR
  A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
•   Wollensak G, Spoerl E, Seiler T
  Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7.
•   Wollensak G, Spoerl E, Seiler T
  Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5.
•   Wollensak G, Spoerl E, Wilsch M, Seiler T
  Endothelial cell damage after riboflavin-ultraviolet-A treatment in the rabbit. J Cataract Refract Surg. 2003 Sep;29(9):1786-90.
•   Yoo SH, Dursun D, Dubovy S, Miller D, Alfonso E, Forster RK, Behar-Cohen F, Parel JM
  Lontophoresis for the treatment of paecilomyces keratitis. Cornea. 2002 Jan;21(1):131-2.
•   Yuksel N, Bilgihan K, Hondur AM
  Herpetic keratitis after corneal collagen cross-linking with riboflavin and ultraviolet-A for progressive keratoconus. Int Ophthalmol. 2011 Dec;31(6):513-5. doi: 10.1007/s10792-011-9489-x. Epub 2011 Dec 3.
•   Zadnik K, Barr JT, Gordon MO, Edrington TB
  Biomicroscopic signs and disease severity in keratoconus. Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study Group. Cornea. 1996 Mar;15(2):139-46. Review.
•   Zadnik K, Steger-May K, Fink BA, Joslin CE, Nichols JJ, Rosenstiel CE, Tyler JA, Yu JA, Raasch TW, Schechtman KB; CLEK Study Group
  Collaborative Longitudinal Evaluation of Keratoconus. Between-eye asymmetry in keratoconus. Cornea. 2002 Oct;21(7):671-9.
•   Zhang ZY, Zhang XR
  Efficacy and safety of transepithelial corneal collagen crosslinking. J Cataract Refract Surg. 2012 Jul;38(7):1304; author reply 1304-5. doi: 10.1016/j.jcrs.2012.05.012.
•   Zhang ZY
  Corneal endothelial damage in the relatively thin cornea after collagen cross-linking treatment. Cornea. 2012 Aug;31(8):967; author reply 967-8. doi: 10.1097/ICO.0b013e31824d4254.

Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

Details for clinical trial NCT01868620