Collagen cross linking with riboflavin and ultraviolet A for the treatment of conical ectasia (progression) in keratoconic corneas: Analysis of clinical outcomes and micro structural changes.

Not Applicable

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

• Registration Number: ACTRN12608000367347
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patient with bilateral keratoconus

2.Patients with documented progressive keratoconus:
3.At least 2 years of follow up data available to accurately map out the rate of progression.
Classified as:
i.Increase in maximal keratometry readings over a period of up to three months
ii.change in refraction reported by patient or referring clinician, over the last 12 months (>0.75 Dioptres )
iii.Several increases of corneal keratometry readings over a period of six months (>0.75 Dioptres)
iv.Progression measured indirectly via by using rigid contact lenses of varying base curves to achieve apical clearance. Ii.e. change in documented contact lens fit in the last 6-12 months.
v.Demonstrated pachyometrical keratoconus worsening over the last six months

4.Participants must be >14 yrs of age < 30 yrs of age.

5.Maximal corneal keratometry reading of no more than 60 Dioptres

6.Minimal corneal thickness measurement of at least 400 µm

7.Preserved best spectacle corrected visual acuity of > 20/80 (6/24)

8.Clear corneas, clinically

9.Well informed patients with the ability to understand the implications of the intervention, such that they are able to consent for themselves

10.Documented rigid gas permeable contact lens intolerance

Exclusion Criteria

1.Previous episodes of corneal hydrops

2.Ocular surgery or trauma

3.Systemic disease which may affect cornea.

4.Demonstrated clinical topographical keratoconus stability in the last 24 months

5.Previous herpetic disease of the cornea.

6.Severe corneal dryness

7.Significant corneal desiccation staining (Grade 2 on the Cornea and Contact Lens Research Unit (CCLRU) grading scale).

8.Minimal corneal thickness of less than 400 µm

9.Evidence of sub-epithelial or mid anterior stromal scarring or opacities

10.Slit lamp examination of marked Vogt striae or confocal evidence of a deep reticular pattern of dark bands (more prone to stromal oedema and corneal haze, due to the procedure)

11.Inability to give informed consent

12.Inability to maintain repeat visits to the Ophthalmology department over a period of months

Study & Design

• Study Type: Interventional
• Study Design: Not specified