Evaluation of a new corneal implant for severe eye conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia

  This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.

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• Brillouin hydration mapping to study cornea health

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• Same-day bilateral corneal cross-linking for keratoconus

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  Recruiting Phase 4 Glaukos Corporation · Westerville, Ohio · NCT07629557

• A Smart Aperture Lens to Help Keratoconus and Presbyopia

  This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.

  Recruiting at 2 sites Azalea Vision · Antwerp and 1 other locations · NCT07559188

• GLK-221 eye drops for keratoconus

  This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.

  Recruiting Phase 2 Glaukos Corporation · Westerville, Ohio · NCT07400952

• Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus

  This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.

  Recruiting Instituto de Oftalmología Fundación Conde de Valenciana · Mexico City, Mexico City · NCT07372911

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.