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

NCT01868620 | Terminated DMC

• 2 other identifiers: 13 030 03HAO
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progressive Keratoconus

Keywords

Progressive keratoconus; standard CXL; iontophoretic CXL; keratometry

Outcome Measures

Primary Outcomes (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.

  Outcome measure is assessed at 1 year.

Secondary Outcomes (1)

• Comparison of minimum keratometry

  3 months

Other Outcomes (7)

• Comparison of mean keratometry

  At 1 year

• Comparison of postoperative pain and complications during the follow up

  Outcome measure is assessed at 1 year and at 3 months

• Comparison of visual acuity

  Outcome measure is assessed at 1 year and at 3 months

Study Arms (2)

Iontophoretic CXL

EXPERIMENTAL

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

Standard CXL

ACTIVE COMPARATOR

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

Interventions

Iontophoretic CXL DEVICE

Iontophoretic CXL

Standard CXL DEVICE

Standard CXL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Sooft Italia: collaborator
• Centre de Référence National du Kératocône: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi-Pyrenees, 31059, France

Location

Related Publications (74)

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Study Officials

• François MALECAZE, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

FR (1)