Prospective, investigator-initiated feasibility study to evaluate the safety, and indicative effectiveness of Gebauer™ lenticules in patients suffering from severe keratoconus or post LASIK ectasia

The Royal Wolverhampton NHS Trust0 个研究点目标入组 15 人开始时间: 2022年3月1日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•1. Diagnosis of either of the following:
•1.1. Severe keratoconus in patients who would prefer to avoid corneal transplant surgery/penetrating keratoplasty
•1.2. Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery/penetrating keratoplasty.
•2. Free of diagnosed terminal illnesses (life expectancy of =2 years)
•3. Aged =18 years and <80 years
•4. Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses
•5. Understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
•6. Able and willing to complete all study visits and comply with the study-specific requirements

•1. History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems
•2. Previous corneal transplantation or corneal implant in the designated eye
•3. Cataract with anticipated surgical intervention (IOL implantation) within 2 years
•4. Active inflammation and/or infection of the eye or the eyelid
•5. IOP <10 mmHg or >21 mmHg
•6. Professionally diagnosed and currently treated autoimmune diseases
•7. Current strong symptoms of any allergy
•8. History of major organ transplantation and/or current continuing immunosuppressive treatment
•9. History of blood transfusion within the last 12 months
•10. Currently participating or has participated in another investigational clinical study within the past 60 days
•11. Pregnancy and lactation

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