Prospective Investigators Initiated Study to Evaluate the Safety and Indicative Effectiveness of XeniaTM custom made ocular implant in subjects having Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The frequency and severity of all treatment- related adverse events, during and after implantation of the XeniaTM and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.
研究概览
简要总结
This is a Prospective open-label, academic investigator initiated clinical study. The primary aim of this study is to assess the safety of implanting the Xenia TM in subjects suffering from Keratoconus. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period. Efficacy will be assessed by measuring the change in best corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity, changes in corneal thickness, corneal clarity and ocular refraction.
The double rationale of using Xenia TM is
-
thicken the pathological cornea using material which is almost identical in structure andcomposition to the corneal stroma improving the BCVA
-
support to the cornea as a whole preventing the progression of the keratoconus disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of keratoconus
- •Visual Acuity with contact lenses must be better than or equal to 20/40
- •Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day
- •Patients will have a minimal corneal thickness of 350 microns
- •In terms of general health, patients must not have any illnesses posing an immediate threat to life
- •Patients must over 18 years of age
- •Patients contact lenses must have been removed at least one week prior to surgery for spft contact lenses and two weeks prior to surgery for hard lenses
- •Must be able to complete all study visits
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study specific tests or procedures are performed.
排除标准
- •Prior corneal surgery in the keratoconus group
- •Corneal scarring
- •History of other ocular pathologies that will interfere with the treatment
- •Active infection of the cornea
- •Subject with history of neurotrophic cornea
- •Subject with history of persistent corneal erosion difficulties with epithelial growth i.e., re epithelization
- •Pregnancy and lactation
- •History of previous ophthalmologic surgery on the operative eye
- •Patients refusing to remove contact lenses one week before surgery for soft lenses and two weeks before surgery for hard lenses
- •Patients with amblyopia, VA less than 20/200 for the contralateral eye
- •Patients with corneal thickness of less than 350 microns
- •Patients with IOP of less than 10 mmHg or than than 21 mmHg
- •Subject who is currently participating or have participated in an investigational study, other than the study, within the past 60 days.
结局指标
主要结局
The frequency and severity of all treatment- related adverse events, during and after implantation of the XeniaTM and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.
时间窗: Day 1, 3, 7, 14 | Week 4, 8, 10, 12 | Month 4, 5, 6, 8, 10, 12
次要结局
- 1. Change in Keratometry [Time Frame: 3 months](2. Subjective corneal clarity)