Corneal Collagen Cross-linking for Keratoconus in the Paediatric Age Group

Not Applicable

Recruiting

• Conditions: keratoconus; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12611001062910
• Lead Sponsor: Royal Victorian Eye and Ear Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Sex: Males or females

2. Age: 10 years to 15 years and 11 months

3. Progression documented by an increase of > 1.00D in the steepest keratometry value (or simK) measured by manual keratometry, automated keratometry or computerised videokeratography or where there is unambiguous documented evidence of progression (in the absence of keratometry) with the agreement of two or more corneal consultants

Exclusion Criteria

1. Keratometry values greater than 60D and contact lens intolerant

2. Corneal pachymetry <400um (thinnest point measured by Orbscan videokeratography or Pentacam and confirmed by ultrasonic pachymetry)

3. History of previous corneal surgery

4. Presence of visually significant corneal scarring

5. Existance of other corneal pathology

6. A history of herpetic keratitis, chemical injury, delayed epithelial healing or recurrent erosion syndrome

7. Pregnancy or breast-feeding at the time of initial treatment

8. Allergy to riboflavin or dextran

9. Unable to comply with follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (LogMAR and Snellen)[1 month, 3 months, 6 months, 12 months, and annually thereafter for 10 years following treatment];Keratometry values[1 month, 3 months, 6 months, 12 months, and annually thereafter for 10 years following treatment]

Secondary Outcome Measures

Name	Time	Method
Time to further procedure (eg. corneal graft)[12 months then annually thereafter for 10 years following treatment];Change in endothelial cell count[1 month, 3 months, 6 months, 12 months, then annual thereafter for 10 years following treatment]