NCT00925041已完成不适用
Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- UCVA 20/40 or better
研究概览
简要总结
The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be undergoing surgery for the correction of myopia
- •Intended treatment from -0.5 to -6.0 D of spherical myopia
- •Must have 0.50 D or less astigmatic component.
- •Must have bilateral physiologic myopia
- •BSCVA of 20/25 or better in each eye
- •Must have had a stable refraction (0.5 D or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old)
- •Patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation
- •Must be at least 18 years of age
- •Corneal topography must be normal, as judged by the investigator
- •Must have a minimal corneal thickness of 475 microns
- •Must sign a written Informed Consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for Informed Consent practices
- •Must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment
排除标准
- •Patients who are unable or unwilling to sign the informed consent form.
- •Anterior segment pathology
- •Residual, recurrent or active ocular disease
- •Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
- •History of herpes keratitis
- •Patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing.
- •Irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus.
- •Patients with known sensitivity to study medications.
- •Intraocular pressure of > 23 mm Hg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect.
- •Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
- •Participation in other ophthalmic clinical trials during this clinical investigation.
结局指标
主要结局
UCVA 20/40 or better
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Feasibility Study of the Vedera KXS for Treatment of KeratoconusKeratoconusNCT01069848Glaukos Corporation23
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
已完成
1 期
Safety, Tolerability & PK of KX2-361 in Subjects w Adv. Malignancies Refractory to Conventional TherapiesAdvance MalignanciesNCT02326441Athenex, Inc.29
进行中（未招募）
不适用
Post Market Clinical Follow-Up KeriFuse®ArthritisNCT06546332Keri Medical SA97