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CompletedPhase 4

Corneal Crosslinking Treatment Study

Key facts

Who runs it
Region Skane
Where
Sweden1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 4
People taking part
54 people enrolled
Started
23 May 2017
Ended
19 Nov 2024
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Corneal crosslinking: CXL (UVA 9mW/cm2)
  • Isotonic riboflavin
  • Hypotonic riboflavin
  • Iontophoresis
Record updated
22 November 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Progress in keratoconic eye. We define progress as an increase in Kmax of 1.0 diopter in 1 year or 0.5 diopter in 6 months. This increase in Kmax will be accepted as progression if concomitant changes tomographic parameters

Who cannot take part

  • Concurrent ocular infection or corneal disease other than keratoconus
  • Treatment with Isotretinoin
  • Pregnancy

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.

The 3 groups in the trial

  • Isotonic riboflavinExisting treatment, for comparison

    CXL (UVA 9mW/cm2) treatment using isotonic riboflavin

    Treatment: Corneal crosslinking: CXL (UVA 9mW/cm2) and Isotonic riboflavin

  • Hypotonic riboflavinExisting treatment, for comparison

    CXL (UVA 9mW/cm2) using hypotonic riboflavin

    Treatment: Corneal crosslinking: CXL (UVA 9mW/cm2) and Hypotonic riboflavin

  • IontophoresisExisting treatment, for comparison

    Iontophoresis with Ricrolin with following CXL (UVA 9mW/cm2).

    Treatment: Corneal crosslinking: CXL (UVA 9mW/cm2) and Iontophoresis

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective Randomised Corneal Crosslinking Study
Publications
Record updated
22 November 2024