NCT01069848已完成不适用
Feasibility Study of the Vedera KXS for Treatment of Keratoconus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The reduction in Kmax (by keratometry) of >1 D
研究概览
简要总结
The objective of this investigation is to evaluate the feasibility, safety and efficacy of the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or glasses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 years of age or older
- •Presence of central or inferior steepening on the Pentacam map
- •Axial topography consistent with keratoconus
- •I-S ratio > 1.5 on the Pentacam map or topography map
- •BSCVA worse than 20/20 (<53 letters on ETDRS chart)
- •Contact Lens Wearers Only: 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
排除标准
- •Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
- •A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
- •Corneal pachymetry <400 microns at diameter 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 corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- •Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
- •A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- •Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
- •Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
结局指标
主要结局
The reduction in Kmax (by keratometry) of >1 D
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of the Vedera KXS for the Treatment of Spherical MyopiaMyopiaNCT00925041Glaukos Corporation40
已完成
3 期
Microwave Treatment and Corneal Collagen Crosslinking for KeratoconusKeratoconusNCT01672814Cornea and Laser Eye Institute3
Unknown
3 期
Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having KeratoconusPost LASIK KeratectasiaKeratoconusNCT02638376Singapore Eye Research Institute66
暂停
早期 1 期
Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP)Posttraumatic Stress DisorderNCT06378528University of Wisconsin, Madison5
进行中（未招募）
1 期
A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)Bone Marrow DiseaseNCT03773393Cellenkos, Inc.18