Efficacy and safety of cross-linking in children with Keratoconus

Corneal cross-linking versus standard care in children with keratoconus, a randomised, multicentre, observer-masked trial of efficacy and safety - KERALINK

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001460-11-GB

Enrollment

Unknown

Registered

2016-05-19

Start date

2016-06-30

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with progressive keratoconus disease MedDRA version: 19.0 Level: PT Classification code 10023353 Term: Keratoconus System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Riboflavin Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Riboflavin Phosphat Other descriptive name: Vitamin B2 Concentration unit: % percent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Children and young patients aged 10-16 years with keratoconus progression confirmed in one or both eyes by Pentacam corneal topography. Progression will be defined as an increase of at least 1.5D in Kmax on corneal topography between two Pentacam examinations at least three months apart. - Patients must be sufficiently fluent in English to provide informed consent and completion of the patient reported outcome measures. - Patients must be willing to attend for follow-up visits. Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Advanced keratoconus as determined by apex corneal scarring. - Apex corneal thickness 60 diopres. - Rigid contact lens wear in both eyes and unable to abstain for 7days pre-examinations. - Corneal co-morbidity. - Down's syndrome. - Any clinical condition which the investigator considers would make the patient unsuitable for the trial, including pregnancy. - Participation in other clinical trials which would materially impact on the Keralink study.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): a) Keratoconus progression (yes/no) defined as >1.5 dioptre increase in Kmax* from baseline (at randomisation) to 18 months or requirement for change from spectacle to rigid contact lenses correction of vision, as the latter precludes reliable topography measures b) Time to Keratoconus progression c) Uncorrected and best corrected visual acuity (measured as logMAR) d) Refraction (measured dioptres spherical equivalent, myopia and astigmatism) e) Central corneal thickness (ultrasound) f) Quality of life as assessed by CHU9D and VF-14 questionnaires ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.	—

Measure

Time frame

Secondary end point(s): a) Keratoconus progression (yes/no) defined as >1.5 dioptre increase in Kmax* from baseline (at randomisation) to 18 months or requirement for change from spectacle to rigid contact lenses correction of vision, as the latter precludes reliable topography measures b) Time to Keratoconus progression c) Uncorrected and best corrected visual acuity (measured as logMAR) d) Refraction (measured dioptres spherical equivalent, myopia and astigmatism) e) Central corneal thickness (ultrasound) f) Quality of life as assessed by CHU9D and VF-14 questionnaires ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.

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Primary

Measure	Time frame
Main Objective: The primary objective of the clinical trial is to establish whether cross-linking is efficacious in stabilising the progression of keratoconus, and whether it is safe in patients under 17 years. The main outcome measure will be the change in Kmax overall in the 2 groups in the time from randomisation and completion of 18 months follow-up. Kmax is an indicator derived from corneal topography and changes in this measure indicate whether keratoconus is progressing or not. Safety of CXL will also be monitored carefully at all follow up time points. ;Secondary Objective: The secondary objectives are to measure the effect of CXL on keratoconus progression from baseline to 18 months in both arms of the trial, including the requirement for change from spectacle to rigid contact lens correction of vision. We will measure keratoconus progression (defined as more than 1.5 dioptres Kmax increase from randomisation) in individual patients, visual acuity with and without glasses or contact lenses, refraction (the measurement for glasses or contact lenses), central corneal thickness, patient-reported visual function and quality of life. Secondary safety outcomes in CXL-treated corneas include corneal opacification, infection and endothelial cell density. ;Primary end point(s): Primary outcome measure is Kmax in the study eye at 18 months post randomisation NB. The study eye is defined as the eye with the more advanced keratoconus at randomisation. The same intervention will be offered for the second eye for patients with progression in both eyes, unless the patient does not wish to receive the same intervention. Information from the second treated eye will be included in secondary analysis. ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.	—

Measure

Time frame

Main Objective: The primary objective of the clinical trial is to establish whether cross-linking is efficacious in stabilising the progression of keratoconus, and whether it is safe in patients under 17 years. The main outcome measure will be the change in Kmax overall in the 2 groups in the time from randomisation and completion of 18 months follow-up. Kmax is an indicator derived from corneal topography and changes in this measure indicate whether keratoconus is progressing or not. Safety of CXL will also be monitored carefully at all follow up time points. ;Secondary Objective: The secondary objectives are to measure the effect of CXL on keratoconus progression from baseline to 18 months in both arms of the trial, including the requirement for change from spectacle to rigid contact lens correction of vision. We will measure keratoconus progression (defined as more than 1.5 dioptres Kmax increase from randomisation) in individual patients, visual acuity with and without glasses or contact lenses, refraction (the measurement for glasses or contact lenses), central corneal thickness, patient-reported visual function and quality of life. Secondary safety outcomes in CXL-treated corneas include corneal opacification, infection and endothelial cell density. ;Primary end point(s): Primary outcome measure is Kmax in the study eye at 18 months post randomisation NB. The study eye is defined as the eye with the more advanced keratoconus at randomisation. The same intervention will be offered for the second eye for patients with progression in both eyes, unless the patient does not wish to receive the same intervention. Information from the second treated eye will be included in secondary analysis. ;Timepoint(s) of evaluation of this end point: The timepoint for evaluation will be the 18 month follow-up visit post randomisation, however, for participants with progression at the 18 month visit a second timepoint at 21 month will be used to confirm this progression.

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Countries

United Kingdom

Contacts

Public ContactClinical Project Manager

UCL CCTU

v.mccudden@ucl.ac.uk+44 (0)20 3108 3942

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026