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Progressive KeratoconusIONTO-CXLNCT01868620

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

A study testing Iontophoretic CXL and Standard CXL in people with Progressive Keratoconus, run by University Hospital, Toulouse at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Progressive Keratoconus
What is being tested?
Iontophoretic CXL and Standard CXL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteFrance
Study dates
May 2013to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • Corneal thickness ≥ 400 µm
  • Progressive stage 1 to 3 keratoconus (Krumeich classification)

Who cannot join

  • Corneal thickness < 400µm
  • Stage 4 keratoconus (Krumeich classification)
  • Concomitant corneal disease
  • History of corneal surgery

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital Toulouse

    Toulouse, Midi-Pyrenees, 31059

Other trials in France

About this study

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.

Read the 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.

Being tested
Iontophoretic CXL, Standard CXL
Keywords
Progressive keratoconus, standard CXL, iontophoretic CXL, keratometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iontophoretic CXLDevice

  • Standard CXLDevice

Study groups in NCT01868620
Study groupRoleWhat they receive
Iontophoretic CXLExperimentalThe 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.
Receives: Device: Iontophoretic CXL
Standard CXLActive comparatorIn 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.
Receives: Device: Standard CXL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main outcome parameter is the non-inferiority of iontophoretic CXL compared to standard CXL in progressive keratoconus

    Measuring maximum keratometry (K-max) derived from computerized videokeratography.

    Measured: Outcome measure is assessed at 1 year.

Secondary outcomes (1)

  1. Comparison of minimum keratometry

    Measure assessed by tomographic measurement.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2016
  4. Study completionMar 2017

Why it stopped: The investigator decided to stop the trial due to a lack of inclusion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868620
Sponsor's protocol ID
13 030 03
Other IDs
HAO
Acronym
IONTO-CXL
Status last verified
Jul 2019
First submitted
29 May 2013
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 6230745

  • 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.

    PubMed 3513592

  • Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.

    PubMed 9493273

  • 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.

    PubMed 8925661

  • 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.

    PubMed 20275788

  • 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.

    PubMed 16633030

  • 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.

    PubMed 12352084

  • 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.

    PubMed 8437824

  • 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.

    PubMed 9584238

  • 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.

    PubMed 17189796

  • 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.

    PubMed 18721713

  • 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.

    PubMed 21902789

  • 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.

    PubMed 22039707

  • 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.

    PubMed 20832121

  • 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.

    PubMed 3309775

Questions about this trial

What is this clinical trial studying?

A study testing Iontophoretic CXL and Standard CXL in people with Progressive Keratoconus, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The investigator decided to stop the trial due to a lack of inclusion.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01868620, which also lists 74 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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