Investigating the safety and improvement of vision for patients suffering from severe keratoconus or post LASIK ectasia after treatment with the Xenia corneal lenticule

Not Applicable

• Conditions: Severe keratoconus or post-LASIK ectasia; Eye Diseases

• Registration Number: ISRCTN17771283
• Lead Sponsor: The Royal Wolverhampton NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Last Update Posted: 26 August 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified