Last reviewed · How we verify
NCT04741230
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule
NA trial testing Gebauer Lenticule in Keratoconus in 15 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | The Royal Wolverhampton Hospitals NHS Trust |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 May 2024 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Gebauer Lenticule
Conditions studied
- Keratoconus — all drugs for Keratoconus →
- Post-Laser Retinal Condition — all drugs for Post-Laser Retinal Condition →
Sponsor
The Royal Wolverhampton Hospitals NHS Trust
Who can join
Adults 18 to 79, any sex, with Keratoconus or Post-Laser Retinal Condition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04741230
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Keratoconus
Currently open trials in the same condition.
- NCT07372911 — PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus · NA · recruiting
- NCT07461129 — Electrophysiological Changes in Cases of Different Stages of Keratoconus · active not recruiting
- NCT06601101 — Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus · Phase 3 · recruiting
- NCT05516004 — Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning · Phase 2 · recruiting
- NCT06798779 — Predicting Manifest Astigmatism in Keratoconus Patients. · active not recruiting
Other The Royal Wolverhampton Hospitals NHS Trust trials
Trials by the same sponsor.
- NCT06581757 — Serum GFAP and UCHL1: Evaluation of Their Predictive Value for SAH · terminated
- NCT05434949 — Pre-analytical Influences on a Blood Test Study · completed
- NCT05196815 — Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aorti · NA · completed
- NCT05177484 — Perioperative Iron for Colorectal Cancer (PICoC Study) · Phase 3 · completed
- NCT05018507 — Variations in Osteoarthritic Knee Laxity Between Individuals and Populations · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04741230 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Royal Wolverhampton Hospitals NHS Trust
- Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04741230.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing