NCT04667572已完成1 期
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- K-Max
研究概览
简要总结
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
详细描述
Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8 years of age or older
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow-up visits
- •Contact Lens Wearers Only:
- •Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
- •And one or more of the following:
- •Presence of central or inferior steepening.
- •Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
- •Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex, Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography
- •Steepest keratometry (Kmax) value ≥ 47.20 D
- •I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map
- •Posterior corneal elevation >16 microns
- •Thinnest corneal point >300 microns
排除标准
- •Eyes classified as either normal or atypical normal on the severity grading scheme.
- •Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
- •Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, etc.) Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
- •Pregnancy (including plan to become pregnant) or lactation during the course of the study
- •A known sensitivity to study medications
- •Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
- •Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
结局指标
主要结局
K-Max
时间窗: 12 Months
Change in K-Max measured by corneal topography, compared to baseline
K-Mean
时间窗: 12 Months
Change in K-Mean measured by corneal topography, compared to baseline
次要结局
- Uncorrected Visual Acuity(12 Months)
- Best Corrected Visual Acuity(12 Months)
- Central Pachymetry(12 Months)
研究者
研究点 (2)
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