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Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Primary Purpose

Keratoconus, Post-Laser Retinal Condition

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gebauer Lenticule
Sponsored by
The Royal Wolverhampton Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gebauer Lenticule

Arm Description

Gebauer Lenticule implant device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
September 18, 2023
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Collaborators
Gebauer Company
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1. Study Identification

Unique Protocol Identification Number
NCT04741230
Brief Title
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Collaborators
Gebauer Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Post-Laser Retinal Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gebauer Lenticule
Arm Type
Experimental
Arm Description
Gebauer Lenticule implant device
Intervention Type
Device
Intervention Name(s)
Gebauer Lenticule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with Immunological rejection by ophthalmic examination of Intraocular pressure, Best corrected visual acuity, Corneal and Lenticule transparency, Inflammation
Description
Signs of immunological rejection during the post implantation observation period
Time Frame
6 months
Title
Treatment-related adverse events.
Description
The frequency and severity of all treatment-related adverse events, during implantation of the Gebauer™ Lenticule and throughout the post implantation observation period.
Time Frame
6 months
Title
Changes in corneal topography (central K-reading results)
Description
Changes in corneal topography (central K-reading results): at baseline vs. post implantation observation period
Time Frame
6 months
Title
Central corneal thickness
Description
Changes in central corneal thickness at baseline vs. post implantation corneal thickness (cornea plus lenticule)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
B Ilango
Phone
01902307999
Email
balasubramaniam.ilango@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Ilango
Organizational Affiliation
The Royal Wolverhampton NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B Ilango
Phone
01902307999
Email
balasubramaniam.ilango@nhs.net

12. IPD Sharing Statement

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Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

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