Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 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
- 否
入选标准
- •Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:
- •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 for the required period of time prior to the screening refraction:
- •Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks
- •Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
- •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
- 未提供
研究组 & 干预措施
Pulsed 6mW/cm2
6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time
干预措施: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Combination Product)
Pulsed 4mW/cm2
4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time
干预措施: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Combination Product)
结局指标
主要结局
K-Max
时间窗: 12 Months
Change in K-Max, compared to baseline
K-Mean
时间窗: 12 Months
Change in K-Mean, compared to baseline
次要结局
- Best Corrected Visual Acuity(12 Months)
- Central Pachymetry(12 Months)
- Uncorrected Visual Acuity(12 Months)