Corneal cross linking in the treatment of juvenile onset early keratoconus

Not Applicable

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

• Registration Number: ACTRN12611000601932
• Lead Sponsor: Dr James MC Alister

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Early Keratoconus must be evidenced by one or more of the following Pentacam derived topographic abnormalities in the study eye

1. Corneal shape factor indicative of keratoconus on Pentacam assessment

Abnormal Enhanced Ectasia Display flags abnormalities based on regression analysis of findings compared to normality indices for
(A) Corneal thickness spatial profile (CTSP)
(B) Percentage thickness increase (PTI)
(C) Deviation parameters (D)

2. Thinnest pachymetry of less than 480microm
3. Kmax of greater than 48 D
4. Posterior corneal elevation of greater than 25 microm on Pentacam analysis

and be associated with patient reported history, topographic or refraction data which indicates one of the following changes notes in less than a 12 month period of follow up.

5. Patient reported history of visual loss in study eye during last 1 year.
6. An increase of greater than or equal to 0.75 Diopters (D) in the steepest keratometry value (Kmax on Pentacam).
7. An increase of greater than than or equal to 0.50D in regular astigmatism evaluated by manifest subjective refraction.
8. A myopic shift (decrease in the spherical equivalent) on manifest refraction of 0.50D.
9. Corneal thinning of greater than or equal to 15 microm in less then 12 months on the same pachymeter.
10. Unaided visual acuity in the study eye falling from logmar equivalent recorded level of 1.0

Patients with other keratoconus characteristics will not be entered into the trial but offered follow up on a 3-6 monthly basis and if there unaided vision falls be invited to participate at that point.

Exclusion Criteria

Exclusion criteria
Eyes will not be eligible to be recruited into the trial if anyone or more of the following apply:
1. Patient age is 18 years or older
2. There is a history of previous corneal surgery.
3. Corneal pachymetry of less than 340microm (thinnest point measured by Pentacam topographer.
4. Insufficient ability to comply with full testing involved in the study
5.The presence of visually significant corneal stromal scarring.
6. The existence of other corneal pathology.
7. A history of herpetic keratitis, chemical injury, or delayed epithelial healing.
8. Recurrent corneal erosion syndrome.
9. Pregnancy or breast-feeding at the time of the initial treatment.
10. Allergy to Riboflavin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified