ACTRN12611000601932终止未知
A prospective comparison of corneal cross linking treatment parameters and outcomes for juvenile onset early keratoconus
Dr James MC Alister0 个研究点目标入组 102 人开始时间: 2011年6月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 17 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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