Efficacy and safety of cross-linking in children with Keratoconus

Phase 1

• Conditions: Patients with progressive keratoconus disease; MedDRA version: 19.0Level: PTClassification code 10023353Term: KeratoconusSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-001460-11-GB
• Lead Sponsor: CL CCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-19
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- Advanced keratoconus as determined by apex corneal scarring.
- Apex corneal thickness <400µ.
- Maximum corneal curvature (Kmax) >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified