NCT04240457终止2 期
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions
Arbor Center for Eye Care2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年7月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Mean Keratometry in Diopters
研究概览
简要总结
To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients 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, intraocular pressure and visual function questionnaire assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomized at outset
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers
- •Subjects who have one or both eyes that meet criteria 1 and one or more of the following criteria will be considered candidates for this study:
- •12 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:
- •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 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 in keratoconus suspect eyes
- •Contact Lens Wearers Only:
- •a. Removal of contact lenses for the required period of time prior to the screening refraction:
- •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 1 Week, Soft Extended Wear 2 Weeks, Soft Toric 3 Weeks, Rigid Gas Permeable 2 Weeks per decade of wear
排除标准
- •(any of the following are reasons for exclusion):
- •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, acanthamoeba, 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
Mean Keratometry in Diopters
时间窗: 1 year
Average keratometry across the anterior topography of the cornea computed by a validated topographer
次要结局
- Best Corrected Visual Acuity With Spectacles or Contact Lenses(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Safety and Effectiveness of the PXL-Platinum 330 SystemCorneal EctasiaPellucid Marginal Corneal DegenerationKeratoconusNCT04401865Colorado Eye Consultants/Cornea Consultants of Colorado300
招募中
2 期
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal EctasiaPellucid Marginal Corneal DegenerationCorneal EctasiaKeratoconusNCT04094090Goodman Eye Center500
招募中
1 期
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-LinkingKeratoconus, UnstableBacterial KeratitisEctasia of CorneaNCT03918408Pacific Clear Vision Institute300
已完成
1 期
Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin SolutionPellucid Marginal Corneal DegenerationCorneal DegenerationCorneal EctasiaKeratoconusNCT04667572Cornea Associates of Texas249
已完成
1 期
Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin SolutionPellucid Marginal Corneal DegenerationCorneal DegenerationCorneal EctasiaKeratoconusNCT04177082Cornea Associates of Texas200