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.

niversity of Auckland0 个研究点目标入组 50 人开始时间: 2008年7月30日最近更新: 2020年1月13日

适应症

试验速览

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•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

•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

发起方

niversity of Auckland