A study looking at a comparison between surgical procedure conceived to increase the stiffness of cornea and standard care (glasses) in children with Keratoconus

Not Applicable

Completed

• Conditions: Specialty: Ophthalmology, Primary sub-specialty: Other; UKCRC code/ Disease: Eye/ Disorders of sclera, cornea, iris and ciliary body; Eye Diseases; Keratoconus

• Registration Number: ISRCTN17303768
• Lead Sponsor: niversity College London

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-10
• Study Completion: 2022-12-31
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified