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

niversity College London0 个研究点目标入组 60 人开始时间: 2016年11月10日最近更新: 2023年1月9日

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2019 Protocol article in http://dx.doi.org/10.1136/bmjopen-2018-028761 protocol (added 23/10/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33892046/ (added 08/12/2022)

•Current inclusion criteria as of 31/01/2019:
•1. Age 10-16 years
•2. Keratoconus progression confirmed in one or both eyes by Pentacam corneal topography. Progression will be defined as an increase of at least 1.5 dioptres in K2 or Kmax on Pentacam corneal topography.
•3. Provision of informed consent and willingness to complete the patient reported outcome measures
•4. Willing to attend for follow up visits
•Previous inclusion criteria:
•1. Age 10-16 years
•2. With keratoconus progression confirmed in one or both eyes by Pentacam cornealtopography. Progression will be defined as an increase of at least 1.5 dioptres in Kmax on corneal topography between two Pentacam examinations at least 3 months apart.
•3. Provision of informed consent and willingness to complete the patient reported outcome measures
•4. Willing to attend for follow up visits

•Current exclusion criteria as of 31/01/2019:
•1. Advanced keratoconus as determined by apex corneal scarring
•2. Apex corneal thickness <400 µm
•3. Steepest corneal meridian (K2) >62 dioptres and maximum corneal curvature (Kmax) >70 dioptres on Pentacam topography at screening
•4. Rigid contact lens wear in both eyes and unable to abstain for 7 days pre-examinations
•5. Corneal comorbidity
•6. Down’s syndrome
•7. Any clinical condition which the investigator considers would make the patient unsuitable for the trial, including pregnancy
•8. Participation in other clinical trials which would materially impact on the Keralink study
•Previous exclusion criteria:
•1. Advanced keratoconus as determined by apex corneal scarring
•2. Apex corneal thickness 60 diopres
•3. Rigid contact lens wear in both eyes and unable to abstain for 7days pre-examinations
•4. Corneal co-morbidity
•5. Down's syndrome
•6. Any clinical condition which the investigator considers would make the patient unsuitable for the trial, including pregnancy
•7. Participation in other clinical trials which would materially impact on the Keralink study

发起方

niversity College London