NL-OMON51085尚未招募不适用
Prospective, open label, single arm, First in Human (FIH) clinical study to assess Safety and efficacy of the CorNeat Keratoprosthesis for the treatment of corneal blindness - Safety assessment of the CorNeat KPro in blind patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female aged >= 18 and <= 80 years on the day of screening
- •2. Candidates must have the ability and willingness to attend all scheduled
- •visits and comply with all study procedures
- •3. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a
- •reasonable option or following a verifiable history of prior failed corneal
- •transplantation.
- •4. Indications that fall under poor candidate for keratoplasty include but are
- •not limited to: herpetic keratitis, vascularized corneal scar, Ocular
- •Cicatricial Pemphigoid, chemical or thermal burn, Steven Johnson Syndrome, and
- •limbal stem cell deficiency;
- •5. Adequate tear film and lid function
- •6. Perception of light in all quadrants
- •7. Female patients of childbearing age must have negative pregnancy test at
- •screening and agree to use an effective method of contraception throughout the
排除标准
- •1. Reasonable chance of success with traditional keratoplasty
- •2. Current retinal detachment
- •3. Connective tissue diseases or severely scarred conjunctiva in the target eye
- •4. End stage glaucoma or evidence of current uncontrolled glaucoma
- •5. History or evidence of severe inflammatory eye diseases (i.e. uveitis,
- •retinitis, scleritis)
- •6. Active inflammation of the conjunctiva in one or both eyes
- •7. History of ocular or periocular malignancy
- •8. History of extensive keloid formation
- •9. Any known intolerance or hypersensitivity to topical anaesthetics,
- •mydriatics, or component of the device, specifically acrylate
- •10. Signs of current infection, including fever and current treatment with
- •antibiotics
- •11. Severe generalized disease that results in a life expectancy shorter than a
- •12. Any clinical evidence that the investigator feels would place the subject
- •at increased risk with the placement of the device
- •13. Currently pregnant or breastfeeding
- •14. Participation in any study involving an investigational drug or device
- •within the past 30 days or 5 half-lives of the drug (whichever longer) or
- •ongoing participation in a study with an investigational drug or device
- •15. Intraoperative complication that would preclude implantation of the study
- •16. Vulnerable populations.
- •17. Active orbital, scleral or corneal inflammation
- •18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced
- •diabetes and/or target organ damage associated with diabetes
- •19. Patients requiring anticoagulation treatment, which cannot be interrupted
- •for the surgical procedure
- •20. Ocular ischemic syndrome
- •21. Severely scarred conjunctiva
研究者
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