Evaluation of a new corneal implant for severe eye conditions
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
This study is testing a new corneal implant to see if it can help people with severe eye conditions like keratoconus and post-LASIK ectasia improve their vision without needing more invasive surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | The Royal Wolverhampton Hospitals NHS Trust Government |
| Locations | 1 site (Wolverhampton, West Midlands) |
| Trial ID | NCT04741230 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the Gebauer™ Lenticule, a novel corneal implant derived from porcine collagen, for treating severe keratoconus and post-LASIK ectasia. The implant is designed for intra-stromal insertion to improve corneal stability without impairing vision, particularly in patients who wish to avoid more invasive surgical options like corneal transplants. The procedure is reversible, allowing for removal of the implant if necessary. Patients will be monitored for outcomes related to vision and corneal health following the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with severe keratoconus or post-LASIK ectasia who prefer to avoid corneal transplant surgery.
Not a fit: Patients with other significant ocular pathologies or those who are not suitable for the procedure due to health concerns may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with severe keratoconus or post-LASIK ectasia, potentially preserving or improving their vision.
How similar studies have performed: While this approach is novel, similar studies evaluating corneal implants have shown promise in improving vision outcomes in patients with corneal ectatic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR * Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty * In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years). * Patients must be aged 18 years or over and less than 80 years old * 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 * Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed * Patient must be able and willing to complete all study visits and comply with the study-specific requirements Exclusion Criteria: * History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems * Previous corneal transplantation or corneal implant in the designated eye * Cataract with anticipated surgical intervention (IOL implantation) within 2 years * Active inflammation and/or infection of the eye or the eye lid * Patients with Intra Ocular Pressure (IOP) \<10 mmHg or \>21 mmHg * Professionally diagnosed and currently treated autoimmune diseases * Current strong symptoms of any allergy * History of major organ transplantation and/or current continuing immunosuppressive treatment * History of blood transfusion within the last 12 months * Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation
Where this trial is running
Wolverhampton, West Midlands
- The Royal Wolverhampton NHS Trust — Wolverhampton, West Midlands, United Kingdom (Recruiting)
Study contacts
- Principal investigator: B Ilango — The Royal Wolverhampton NHS Trust
- Study coordinator: B Ilango
- Email: balasubramaniam.ilango@nhs.net
- Phone: 01902307999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.