Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- PXL-Platinum 330 system
研究概览
简要总结
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.
详细描述
The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal curvature and biomechanical anomalies associated with corneal thinning conditions, e.g., progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of patients with bacterial or fungal keratitis.
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
- Single (Investigator)
盲法说明
Subjects will be assigned randomly to either pulsed or continuous lighting.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •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: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with Bowman's breaks g. Scissoring of the retinoscopic reflex h. Crab-claw appearance on topography
- •Steepest keratometry (Kmax) value ≥ 47.20 D.
- •I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map.
- •Posterior corneal elevation >16 microns.
- •Thinnest corneal point <485 microns.
- •Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s
- •Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid. progression of corneal thinning, with loss of >25% corneal thickness
- •Contact Lens Wearers Only: a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear
- •Signed written informed consent.
- •Willingness and ability to comply with schedule for follow-up.
排除标准
- •Eyes classified as either normal or atypical normal on the severity grading scheme.
- •Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.
- •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, acanthomeoeba, 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
PXL-Platinum 330 system
时间窗: 12 months
Keratometry
次要结局
未报告次要终点
研究者
Vishal Jhanji
Professor of Ophthalmology
University of Pittsburgh