NCT03918408招募中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
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Mean keratometry in diopters
研究概览
简要总结
To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
详细描述
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Randomized at outset
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, 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 & 2 and 1 or more of the following criteria will be considered candidates for this study.
- •12 years of age or older
- •Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
- •Presence of central or inferior steepening.
- •Axial topography consistent with keratoconus
- •Presence of one or more findings associated with keratoconus 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/Galilei/Orbscan/Cassini map or topography map
- •Posterior corneal elevation >16 microns
- •Thinnest corneal point <485 microns
- •AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow-up visits
- •For 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
- •Scleral Lenses
- •Investigator Discretion [Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening]
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow-up visits
- •Exclusion Criteria (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 <330 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 active medical implants (e.g. cardiac pacemakers)'
- •Patients who are aphakic/ pseudophakic
排除标准
- 未提供
结局指标
主要结局
Mean keratometry in diopters
时间窗: 12 months
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
次要结局
- Best corrected visual acuity(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning PositionKeratoconus, UnstableEctasia CornealBacterial KeratitisNCT04213885Eye Specialists of Indiana12
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
终止
2 期
Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic ConditionsCornea EctasiaKeratoconusNCT04240457Arbor Center for Eye Care11
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