KeratoconusNCT04741230
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
A study testing Gebauer Lenticule in people with Keratoconus and Post-Laser Retinal Condition, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Keratoconus, Post-Laser Retinal Condition
- What is being tested?
- Gebauer Lenticule
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
B Ilango, 01902307999, balasubramaniam.ilango@nhs.net
About this study
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
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
- Being tested
- Gebauer Lenticule
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gebauer LenticuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gebauer Lenticule | Experimental | Gebauer Lenticule implant device Receives: Device: Gebauer Lenticule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 6 months
Central corneal thickness
Changes in central corneal thickness at baseline vs. post implantation corneal thickness (cornea plus lenticule)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Gebauer Company
- Responsible party
- Sponsor
- Investigators
- B Ilango, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741230
- Sponsor's protocol ID
- 2019OPH108
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04741230
- Acronym / sponsor ID
- 2019OPH108
- Conditions
- Keratoconus, Post-Laser Retinal Condition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- Gebauer Company
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gebauer Lenticule | Experimental | Device: Gebauer LenticuleGebauer Lenticule implant device |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gebauer LenticuleThe 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. | Device | Gebauer Lenticule |
Primary outcome
Number of participants with Immunological rejection by ophthalmic examination of Intraocular pressure, Best corrected visual acuity, Corneal and Lenticule transparency, Inflammation
Time frame: 6 months
Signs of immunological rejection during the post implantation observation period
Treatment-related adverse events.
Time frame: 6 months
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)
Time frame: 6 months
Changes in corneal topography (central K-reading results): at baseline vs. post implantation observation period
Central corneal thickness
Time frame: 6 months
Changes in central corneal thickness at baseline vs. post implantation corneal thickness (cornea plus lenticule)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
B Ilango principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gebauer Lenticule in people with Keratoconus and Post-Laser Retinal Condition, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact B Ilango (01902307999, balasubramaniam.ilango@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Immunological rejection by ophthalmic examination of Intraocular pressure, Best corrected visual acuity, Corneal and Lenticule transparency, Inflammation (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.