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

Progressive Keratoconus Clinical Trial

— IONTO-CXL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01868620
• Other study ID #: 13 030 03
• Secondary ID: HAO
• Status: Terminated
• Phase: N/A
• Start date: May 2013
• Est. completion date: March 2017

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus
• Progressive Keratoconus

Intervention

Device:
• Iontophoretic CXL

• Standard CXL

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse	Midi-Pyrenees

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre de Référence National du Kératocône, Sooft Italia

Country where clinical trial is conducted

France, 

References & Publications (74)

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* Note: There are 74 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of mean keratometry	Tomographic measurement.	At 1 year
Other	Comparison of postoperative pain and complications during the follow up		Outcome measure is assessed at 1 year and at 3 months
Other	Comparison of visual acuity		Outcome measure is assessed at 1 year and at 3 months
Other	Intraoperative comparison of corneal concentration of riboflavin		Outcome measure is assessed at 1 year and at 3 months
Other	Comparison of depth of treatment	By tomographic measurement	Outcome measure is assessed at 1 year and at 3 months
Other	Comparison of biomechanical parameters	By ORA (Ocular Response Analyzer)	Outcome measure is assessed at 1 year and at 3 months
Other	Comparison of corneal thickness		Outcome measure is assessed at 1 year and at 3 months for the tomographic measurement.
Primary	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.	Outcome measure is assessed at 1 year.
Secondary	Comparison of minimum keratometry	Measure assessed by tomographic measurement.	3 months