Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.
NCT ID: NCT01868620
Last Updated: 2019-07-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
28 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Study Completion Date
2017-03-31
Brief Summary
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The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.
Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.
Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.
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Detailed Description
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Keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. CXL has changed the natural evolution of keratoconus. It creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. The corneal stroma is soaked with a riboflavin solution before being exposed to ultraviolet-A radiation.
In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infection and stromal opacity due to corneal scarring.
Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of riboflavin into the cornea. The iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement.
In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infection and stromal opacity due to corneal scarring.
Iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of riboflavin into the cornea. The iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement.
Conditions
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Progressive Keratoconus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Iontophoretic CXL
The iontophoretic CXL involves a constant current source and two electrodes. The main electrode is a circular cup, with a surrounding annular suction ring to affix the device on the cornea during the procedure. The electrode itself is a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with riboflavin solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated by a UVA light for 3mW/cm2 during 30 minutes.
Group Type
EXPERIMENTAL
Iontophoretic CXL
Intervention Type
DEVICE
Standard CXL
In the standard CXL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes.
Group Type
ACTIVE_COMPARATOR
Standard CXL
Intervention Type
DEVICE
Interventions
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Iontophoretic CXL
Intervention Type
DEVICE
Standard CXL
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)
* Corneal thickness ≥ 400 µm
* Progressive stage 1 to 3 keratoconus (Krumeich classification)
Exclusion Criteria
* Corneal thickness \< 400µm
* Stage 4 keratoconus (Krumeich classification)
* Concomitant corneal disease
* History of corneal surgery
* Stage 4 keratoconus (Krumeich classification)
* Concomitant corneal disease
* History of corneal surgery
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sooft Italia
INDUSTRY
Sponsor Role
collaborator
Centre de Référence National du Kératocône
OTHER
Sponsor Role
collaborator
University Hospital, Toulouse
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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François MALECAZE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Locations
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University Hospital Toulouse
Toulouse, Midi-Pyrenees, France
Site Status
Countries
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France
References
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Krachmer JH, Feder RS, Belin MW. Keratoconus and related noninflammatory corneal thinning disorders. Surv Ophthalmol. 1984 Jan-Feb;28(4):293-322. doi: 10.1016/0039-6257(84)90094-8.
Reference Type
BACKGROUND
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. doi: 10.1016/0002-9394(86)90817-2.
Reference Type
BACKGROUND
Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
Reference Type
BACKGROUND
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. doi: 10.1097/00003226-199603000-00006.
Reference Type
BACKGROUND
AMSLER M. [Classic keratocene and crude keratocene; Unitary arguments]. Ophthalmologica. 1946 Feb-Mar;111(2-3):96-101. doi: 10.1159/000300309. No abstract available. French.
Reference Type
BACKGROUND
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. doi: 10.1097/01.ico.0000178728.57435.df.
Reference Type
BACKGROUND
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. doi: 10.1097/00003226-200210000-00008.
Reference Type
BACKGROUND
Rabinowitz YS, Nesburn AB, McDonnell PJ. Videokeratography of the fellow eye in unilateral keratoconus. Ophthalmology. 1993 Feb;100(2):181-6. doi: 10.1016/s0161-6420(93)31673-8.
Reference Type
BACKGROUND
Krumeich JH, Daniel J, Knulle A. Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998 Apr;24(4):456-63. doi: 10.1016/s0886-3350(98)80284-8.
Reference Type
BACKGROUND
Colin J, Malet FJ. Intacs for the correction of keratoconus: two-year follow-up. J Cataract Refract Surg. 2007 Jan;33(1):69-74. doi: 10.1016/j.jcrs.2006.08.057.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Arne JL, Fournie P. [Keratoconus, the most common corneal dystrophy. Can keratoplasty be avoided?]. Bull Acad Natl Med. 2011 Jan;195(1):113-29. French.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1016/s0161-6420(87)33356-1.
Reference Type
BACKGROUND
Kirkness CM, Ficker LA, Steele AD, Rice NS. The success of penetrating keratoplasty for keratoconus. Eye (Lond). 1990;4 ( Pt 5):673-88. doi: 10.1038/eye.1990.95.
Reference Type
BACKGROUND
The Australian Corneal Graft Registry. 1990 to 1992 report. Aust N Z J Ophthalmol. 1993 May;21(2 Suppl):1-48.
Reference Type
BACKGROUND
Borderie VM, Boelle 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.
Reference Type
BACKGROUND
Spoerl E, Huhle M, Seiler T. Induction of cross-links in corneal tissue. Exp Eye Res. 1998 Jan;66(1):97-103. doi: 10.1006/exer.1997.0410.
Reference Type
BACKGROUND
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. doi: 10.1016/s0886-3350(03)00407-3.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1016/s0002-9394(02)02220-1.
Reference Type
BACKGROUND
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. doi: 10.1016/j.jcrs.2006.01.091.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1111/j.1442-9071.2007.01536.x.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1016/j.jcrs.2007.06.036.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Vinciguerra P, Albe 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. No abstract available.
Reference Type
BACKGROUND
Rodriguez-Ausin P, Gutierrez-Ortega R, Arance-Gil A, Romero-Jimenez M, Fuentes-Paez G. Keratopathy after cross-linking for keratoconus. Cornea. 2011 Sep;30(9):1051-3. doi: 10.1097/ICO.0b013e3182096789.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. No abstract available.
Reference Type
BACKGROUND
Costello CT, Jeske AH. Iontophoresis: applications in transdermal medication delivery. Phys Ther. 1995 Jun;75(6):554-63. doi: 10.1093/ptj/75.6.554.
Reference Type
BACKGROUND
von Sallmann L. Iontophoretic introduction of atropine and scopolamine into the rabbit eye. Arch Ophthalmol 1943;29:711-9.
Reference Type
BACKGROUND
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. doi: 10.1016/s0014-4835(66)80009-x. No abstract available.
Reference Type
BACKGROUND
Hughes L, Maurice DM. A fresh look at iontophoresis. Arch Ophthalmol. 1984 Dec;102(12):1825-9. doi: 10.1001/archopht.1984.01040031483028.
Reference Type
BACKGROUND
Lam TT, Edward DP, Zhu XA, Tso MO. Transscleral iontophoresis of dexamethasone. Arch Ophthalmol. 1989 Sep;107(9):1368-71. doi: 10.1001/archopht.1989.01070020438050.
Reference Type
BACKGROUND
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. No abstract available. French.
Reference Type
BACKGROUND
Behar-Cohen FF, Savoldelli M, Parel JM, Goureau O, Thillaye-Goldenberg B, Courtois Y, Pouliquen Y, de Kozak Y. Reduction of corneal edema in endotoxin-induced uveitis after application of L-NAME as nitric oxide synthase inhibitor in rats by iontophoresis. Invest Ophthalmol Vis Sci. 1998 May;39(6):897-904.
Reference Type
BACKGROUND
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. doi: 10.1006/exer.1997.0364.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1097/00003226-200201000-00029. No abstract available.
Reference Type
BACKGROUND
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. doi: 10.1089/108076803321637672.
Reference Type
BACKGROUND
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. doi: 10.1136/bjo.2004.048314.
Reference Type
BACKGROUND
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. doi: 10.1006/exer.2001.1098.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1016/s0886-3350(03)00343-2.
Reference Type
BACKGROUND
Spoerl E, Seiler T. Techniques for stiffening the cornea. J Refract Surg. 1999 Nov-Dec;15(6):711-3. doi: 10.3928/1081-597X-19991101-21.
Reference Type
BACKGROUND
Chien YW, Banga AK. Iontophoretic (transdermal) delivery of drugs: overview of historical development. J Pharm Sci. 1989 May;78(5):353-4. doi: 10.1002/jps.2600780502. No abstract available.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Asri D, Touboul D, Fournie 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Touboul D, Robinet-Perrin A, Fournie 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. French.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HAO
Identifier Type: OTHER
Identifier Source: secondary_id
13 030 03
Identifier Type: -
Identifier Source: org_study_id
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