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

CL CCT0 个研究点开始时间: 2016年5月19日最近更新: 2017年1月23日

试验速览

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•- 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

•- 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.

发起方

CL CCT