Prospective Post-Marketing Clinical Follow-Up (PMCF) Study to Evaluate the Performance of Custom-Made XENIA™ Corneal Implants for The Treatment of Presbyopia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary Safety Outcome- The frequency and severity of all treatment-related adverse events, during and post implantation of Xenia™ 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
Gebauer Medizintechnik GmbH hasdeveloped Xenia™ custom made corneal implant that will be used to treat presbyopia.Xenia™ is an acellular porcine corneal stromal collagen scaffold which has beencleared of all donor’s cells and its cellular remnants, as for example lipids,peptides, sugars or kernel content as DNA.
Previous studies have shownimmunological safety of the Xenia™ material (natural cornealcollagen of porcine origin).
Patients taking part in the study cansignificantly benefit from the procedure in that their near vision is restoredwith a minimally invasive surgical procedure (much less invasive as compared toimplantation of presbyopia-correcting IOL).
The double rationale of using Xenia™ is
1. thicken the pathological cornea using materialwhich is almost identical in structure and composition to the cornealstroma improving the BCVA.
2. support the corneaas a whole preventing the progression of presbyopia.
The procedure is an additive procedureas well as reversible, i.e., the implant can be removed and the initial visionfrom before the implantation is restored. Due to the transparency of thecornea, the implant can be always visualized, which is beneficial formonitoring purposes.
This is a Post Marketing Clinical Follow Up (PMCF) tostudy the safety and indicative effectiveness of Xenia™, which is a custom-madecorneal Implant
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
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female Subjects having Age between 40 years and above.
- •2.Willing to provide voluntary written consent.
- •3.No diagnosis of glaucoma, ocular hypertension, and severe dry eye disease 4.Having Presbyopia and having no or very marginal remaining accommodation capability or Pseudophake patients with standard (mono-focal) IOL 5.Emmetropic patients (or minimally myopic patients) 6.Needing about +1.5 diopters add for near vision 7.Must be able to tolerate Monovision of at least 1.5 diopters 8.Must be accessible and willing to attend all follow-up visits.
排除标准
- •1.Patients with IOP less than 10 mmHg or more than 21 mmHg. 2.Implanted with presbyopia-correcting IOLs (EDOF or Multifocal) 3.Prior LASIK or other corneal surgery 4.History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems.
- •5.Metabolic problems, e.g., diabetes or inflammatory concerns 6.Corneal scarring 7.Active infection of the cornea 8.Subject with history of neurotrophic cornea.
- •9.Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization) 10.Pregnancy and lactation.
- •11.History of previous ophthalmologic surgery on the operative eye.
- •12.Patients with amblyopia (VA less than 20/200 for the contralateral eye).
- •13.Patients with an uncooperative disposition.
- •14.Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
- •15.Other factors considered unsuitable by Investigator.
结局指标
主要结局
Primary Safety Outcome- The frequency and severity of all treatment-related adverse events, during and post implantation of Xenia™ 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 | Month 1, 3, 6, 12
Primary Effectiveness Outcome- Change in Distance-corrected near visual acuity (DCNVA) compared to baseline (Achievement of a greater or equal to 3-line (15 letters) gain from baseline in DCNVA at 40 cm with no loss in CDVA greater or equal to 1-line (5 letters) at 4 m Month 1 post implantation)
时间窗: Day 1-3, 7, 14 | Month 1, 3, 6, 12
次要结局
- 1.No significant change in keratometry parameters (measured on pentacam) [Time Frame: 3 Months](2.Subjective corneal clarity)