Trial record 1 of 1 for:    NCT01868620
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Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. (IONTO-CXL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Toulouse
Sponsor:
Collaborators:
Sooft Italia
Centre de Référence National du Kératocône (CRNK)
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01868620
First received: May 29, 2013
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Progressive Keratoconus
Device: Iontophoretic CXL
Device: Standard CXL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • The main outcome parameter is the non-inferiority of iontophoretic CXL compared to standard CXL in progressive keratoconus [ Time Frame: Outcome measure is assessed at 1 year. ] [ Designated as safety issue: No ]
    Measuring maximum keratometry (K-max) derived from computerized videokeratography.


Secondary Outcome Measures:
  • Comparison of minimum keratometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure assessed by tomographic measurement.


Other Outcome Measures:
  • Comparison of mean keratometry [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
    Tomographic measurement.

  • Comparison of postoperative pain and complications during the follow up [ Time Frame: Outcome measure is assessed at 1 year and at 3 months ] [ Designated as safety issue: Yes ]
  • Comparison of visual acuity [ Time Frame: Outcome measure is assessed at 1 year and at 3 months ] [ Designated as safety issue: No ]
  • Intraoperative comparison of corneal concentration of riboflavin [ Time Frame: Outcome measure is assessed at 1 year and at 3 months ] [ Designated as safety issue: No ]
  • Comparison of depth of treatment [ Time Frame: Outcome measure is assessed at 1 year and at 3 months ] [ Designated as safety issue: No ]
    By tomographic measurement

  • Comparison of biomechanical parameters [ Time Frame: Outcome measure is assessed at 1 year and at 3 months ] [ Designated as safety issue: No ]
    By ORA (Ocular Response Analyzer)

  • Comparison of corneal thickness [ Time Frame: Outcome measure is assessed at 1 year and at 3 months for the tomographic measurement. ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Iontophoretic CXL
Active Comparator: 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.
Device: Standard CXL

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868620

Contacts
Contact: François MALECAZE, MD, PhD 0561777752 ext 33 malecaze.fr@chu-toulouse.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, Midi-Pyrenees, France, 31059
Contact: François MALECAZE, MD, PhD    0561777752 ext 33    malecaze.fr@chu-toulouse.fr   
Contact: Pierre FOURNIE, MD, PhD    0561777404 ext 33    fournie.p@chu-toulouse.fr   
Principal Investigator: François MALECAZE, MD, PhD         
Sub-Investigator: Pierre FOURNIE, MD, PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Sooft Italia
Centre de Référence National du Kératocône (CRNK)
Investigators
Principal Investigator: François MALECAZE, MD, PhD
  More Information

Publications:
Rabinowitz YS. Keratoconus. Surv Ophthalmol 1998;42:297-319
Cheng YY, Visser N, Schouten JS, Wijdh RJ, Pels E, van Cleynenbreugel H, et al. Endothelial cell loss and visual outcome of deep anterior lamellar keratoplasty versus penetrating keratoplasty: a randomized multicenter clinical trial. Ophthalmology 2011;118:302-9.
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;36:2105-14.
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;5:152.
Caporossi A, Mazzotta C, Baiocchi S, Cporossi T, Paradiso AL. Transepithelial corneal collagen crosslinking for keratoconus: qualitative investigation by in vivo HRT II confocal analysis. Eur J Ophthalmol 2012;22:81-8.
Filipello M, Stagni E, O'Brart D. Transepithelial corneal collagen crosslinking: bilateral study. J Cataract Refract Surg 2012;38:283-91.
Filippello M, Stagni E, O'Brart D. Reply: Efficacy and safety of transepithelial corneal collagen crosslinking. J Cataract Refract Surg 2012;38:1304-5.
Leccisotti A, Islam T. Transepithelial corneal collagen cross-linking in keratoconus. J Refract Surg 2010;26:942-8.
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;38:1000-5.
Zhang ZY, Zhang XR. Efficacy and safety of transepithelial corneal collagen crosslinking. J Cataract Refract Surg 2012;38:1304.
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;118:209-18.
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;149:585-93. Epub 2010 Feb 6.
Asri D, Touboul D, Fournié P, Malet F, Garra C, Gallois A, et al. Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Center for Keratoconus. J Cataract Refract Surg 2011;37:2137-43.
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 Jun 5.

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01868620     History of Changes
Other Study ID Numbers: 13 030 03, HAO
Study First Received: May 29, 2013
Last Updated: July 25, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
Progressive keratoconus
standard CXL
iontophoretic CXL
keratometry

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 29, 2014