Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

NCT04741230 | Recruiting

• 1 other identifier: 2019OPH108
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cornea ectatic conditions such as keratoconus and post-LASIK (Laser In situ Keratomileusis) ectasia are disorders of the eye that are notorious for its uncontrolled progression over time, leading to loss of vision. There are valuable treatment options for controlling disease progression in mild to moderate stages of such disease. However in advanced cases and / or when contact lenses cannot be worn, surgery remains the only treatment option to rehabilitate vision. Most treatment options are highly invasive and represent significant risks. This study evaluates a novel corneal implant, Gebauer™ Lenticule to treat severe keratoconus or post-LASIK ectasia. This implant is derived from porcine collagen and intended for intra-stromal insertion. The Gebauer™ Lenticule is expected to improve the stability of the cornea while not impairing the vision. The procedure is an additive procedure after other treatment options have been exhausted. The procedure is reversible with removal of the implant (in the unexpected case of an adverse reaction), and vision may be restored to baseline. The purpose of this study is to evaluate how well the implant is tolerated, it's safety profile, and how effective this new treatment option is in the treatment of keratoconus or post-LASIK ectasia.

Conditions

Keratoconus; Post-Laser Retinal Condition

Outcome Measures

Primary Outcomes (4)

• Number of participants with Immunological rejection by ophthalmic examination of Intraocular pressure, Best corrected visual acuity, Corneal and Lenticule transparency, Inflammation

  Signs of immunological rejection during the post implantation observation period

  6 months

• Treatment-related adverse events.

  The frequency and severity of all treatment-related adverse events, during implantation of the Gebauer™ Lenticule and throughout the post implantation observation period.

  6 months

• Changes in corneal topography (central K-reading results)

  Changes in corneal topography (central K-reading results): at baseline vs. post implantation observation period

  6 months

• Central corneal thickness

  Changes in central corneal thickness at baseline vs. post implantation corneal thickness (cornea plus lenticule)

  6 months

Study Arms (1)

Gebauer Lenticule

EXPERIMENTAL

Gebauer Lenticule implant device

Device: Gebauer Lenticule

Interventions

Gebauer Lenticule DEVICE

The Gebauer™ Lenticule corneal implant device is a custom-made device intended for patients suffering from keratoconus or post-LASIK ectasia. The device is expected to reinforce and stabilize the patient's cornea, so that a more consistent refraction is induced and a penetrating human cornea donor transplantation may be avoided or postponed.

Gebauer Lenticule

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Gebauer Company: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• B Ilango

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

B Ilango

CONTACT

01902307999; balasubramaniam.ilango@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

GB (1)