Neurotrophic Corneal UlcerNCT05809245
Corneal Neurotization as a Treatment for Neurotrophic Keratopathy
A study testing Corneal neurotization in people with Neurotrophic Corneal Ulcer and Neurotrophic Keratitis, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurotrophic Corneal Ulcer, Neurotrophic Keratitis, Cranial Nerve V Diseases
- What is being tested?
- Corneal neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with neurotrophic cornea
Who cannot join
- Patients with history of penetrating keratoplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Neurotization Via Sural Nerve Transfer or Cadaveric Nerve Graft for Neurotrophic Keratopathy
The purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy.
Read the detailed description
Corneal anesthesia, which can lead to visually devastating outcomes from ulceration, perforation, and scarring, can be recalcitrant to both medical and surgical treatment[1-3]. Neurotization is a revolutionary technique reported to restore corneal sensation in neurotrophic keratopathy[4-6]. Prior techniques described include direct neurotization with contralateral supraorbital and supratrochlear nerves accessed via a bicoronal incision of the scalp over the forehead[5]; nerve grafting with contralateral supratrochlear nerves accessed via a medial upper eyelid incision[6]; and sural nerve grafting to contralateral supratrochlear nerves accessed via a transverse incision over the medial upper eyelid[4]. Despite the challenges associated with these techniques (needing to subcutaneously tunnel the nerve graft over the nasal bridge or requiring a large bicoronal incision), these techniques all demonstrated efficacy in direct neurotization to improve corneal sensation in these patients.
The investigators aim to assess the efficacy of this innovative surgical technique involving coaptation of the sural nerve or cadaveric nerve allograft to an intact sensory branch of the trigeminal nerve to restore corneal sensation. The investigators have previously described the anatomic feasibility of using the infraorbital nerve using a cadaveric model, of which the results were presented at the American Society of Ophthalmic Plastic and Reconstructive Society Fall meeting in 2017. Utilization of the infraorbital nerve provides advantages over existing techniques due to ease of access via a cosmetically favorable incision, large caliber with increased ability to create a perineural window, relatively short and direct tunnel with possibly more rapid neurotization, and absence of complex surrounding anatomical structures. Others have previously describe success using the contralateral and ipsilateral supraorbital nerve and supratrochlear nerve.
- Being tested
- Corneal neurotization
- Keywords
- Corneal neurotization, neurotrophic cornea, neurotrophic corneal ulcer
- Medical subject headings
- Trigeminal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal neurotizationProcedure or surgery
Autologous sural nerve will be harvested or cadaveric nerve graft will be coapted to an intact sensory branch of the trigeminal nerve. The nerve will be separated into fascicles which will be tunneled under the conjunctiva around the cornea near the limbus.
| Study group | Role | What they receive |
|---|---|---|
| Corneal neurotization | Experimental | Patients will undergo the corneal neurotization as described in the protocol. Their pre and post-procedure corneal sensation will be measured as a primary outcome measure. Secondary outcome measures will include visual acuity, corneal opacity, NEI VFQ, and confocal microscopy. Receives: Procedure: Corneal neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal sensation
Corneal sensation will be measured via Cochet Bonnet esthesiometry
Measured: Baseline (pre-operative) to 12 months postoperatively
Secondary outcomes (2)
Visual acuity
Measurement using Snellen eye chart
Measured: Baseline (pre-operative) to 12 months postoperatively
Corneal opacity
Measured based on grade 0-4 based on degree of opacity.
Measured: Baseline (pre-operative) to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start15 Mar 2018
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neurotrophic Corneal UlcerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea L Kossler, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809245
- Sponsor's protocol ID
- 43284
- Status last verified
- Mar 2023
- First submitted
- 14 May 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramaesh K, Stokes J, Henry E, Dutton GN, Dhillon B. Congenital corneal anesthesia. Surv Ophthalmol. 2007 Jan-Feb;52(1):50-60. doi: 10.1016/j.survophthal.2006.10.004.
PubMed 17212990Bonini S, Rama P, Olzi D, Lambiase A. Neurotrophic keratitis. Eye (Lond). 2003 Nov;17(8):989-95. doi: 10.1038/sj.eye.6700616.
PubMed 14631406Mantelli F, Nardella C, Tiberi E, Sacchetti M, Bruscolini A, Lambiase A. Congenital Corneal Anesthesia and Neurotrophic Keratitis: Diagnosis and Management. Biomed Res Int. 2015;2015:805876. doi: 10.1155/2015/805876. Epub 2015 Sep 16.
PubMed 26451380Elbaz U, Bains R, Zuker RM, Borschel GH, Ali A. Restoration of corneal sensation with regional nerve transfers and nerve grafts: a new approach to a difficult problem. JAMA Ophthalmol. 2014 Nov;132(11):1289-95. doi: 10.1001/jamaophthalmol.2014.2316.
PubMed 25010775Terzis JK, Dryer MM, Bodner BI. Corneal neurotization: a novel solution to neurotrophic keratopathy. Plast Reconstr Surg. 2009 Jan;123(1):112-120. doi: 10.1097/PRS.0b013e3181904d3a.
PubMed 19116544Sepehripour S, Lloyd MS, Nishikawa H, Richard B, Parulekar M. Surrogate Outcome Measures for Corneal Neurotization in Infants and Children. J Craniofac Surg. 2017 Jul;28(5):1167-1170. doi: 10.1097/SCS.0000000000003677.
PubMed 28570404
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Neurotization Via Sural Nerve Transfer or Cadaveric Nerve Graft for Neurotrophic Keratopathy
- ClinicalTrials.gov ID
- NCT05809245
- Acronym / sponsor ID
- 43284
- Keywords
- Corneal neurotization, neurotrophic cornea, neurotrophic corneal ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 12 Apr 2023 (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.
The purpose of this study is to assess the efficacy of sural nerve transfer and cadaveric nerve graft to re-establish corneal sensation in patients with neurotrophic keratopathy.
Detailed description
Corneal anesthesia, which can lead to visually devastating outcomes from ulceration, perforation, and scarring, can be recalcitrant to both medical and surgical treatment[1-3]. Neurotization is a revolutionary technique reported to restore corneal sensation in neurotrophic keratopathy[4-6]. Prior techniques described include direct neurotization with contralateral supraorbital and supratrochlear nerves accessed via a bicoronal incision of the scalp over the forehead[5]; nerve grafting with contralateral supratrochlear nerves accessed via a medial upper eyelid incision[6]; and sural nerve grafting to contralateral supratrochlear nerves accessed via a transverse incision over the medial upper eyelid[4]. Despite the challenges associated with these techniques (needing to subcutaneously tunnel the nerve graft over the nasal bridge or requiring a large bicoronal incision), these techniques all demonstrated efficacy in direct neurotization to improve corneal sensation in these patients.
The investigators aim to assess the efficacy of this innovative surgical technique involving coaptation of the sural nerve or cadaveric nerve allograft to an intact sensory branch of the trigeminal nerve to restore corneal sensation. The investigators have previously described the anatomic feasibility of using the infraorbital nerve using a cadaveric model, of which the results were presented at the American Society of Ophthalmic Plastic and Reconstructive Society Fall meeting in 2017. Utilization of the infraorbital nerve provides advantages over existing techniques due to ease of access via a cosmetically favorable incision, large caliber with increased ability to create a perineural window, relatively short and direct tunnel with possibly more rapid neurotization, and absence of complex surrounding anatomical structures. Others have previously describe success using the contralateral and ipsilateral supraorbital nerve and supratrochlear nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal neurotization | Experimental | Procedure: Corneal neurotizationPatients will undergo the corneal neurotization as described in the protocol. Their pre and post-procedure corneal sensation will be measured as a primary outcome measure. Secondary outcome measures will include visual acuity, corneal opacity, NEI VFQ, and confocal microscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with neurotrophic cornea
Key exclusion criteria (1 listed)
- Patients with history of penetrating keratoplasty
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 |
|---|---|---|
| Corneal neurotizationAutologous sural nerve will be harvested or cadaveric nerve graft will be coapted to an intact sensory branch of the trigeminal nerve. The nerve will be separated into fascicles which will be tunneled under the conjunctiva around the cornea near the limbus. | Procedure or surgery | Corneal neurotization |
Primary outcome
Corneal sensation
Time frame: Baseline (pre-operative) to 12 months postoperatively
Corneal sensation will be measured via Cochet Bonnet esthesiometry
2 secondary outcomes
Visual acuity
Time frame: Baseline (pre-operative) to 12 months postoperatively
Corneal opacity
Time frame: Baseline (pre-operative) to 12 months postoperatively
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 17212990Ramaesh K, Stokes J, Henry E, Dutton GN, Dhillon B. Congenital corneal anesthesia. Surv Ophthalmol. 2007 Jan-Feb;52(1):50-60. doi: 10.1016/j.survophthal.2006.10.004.
- Background: PubMed 14631406Bonini S, Rama P, Olzi D, Lambiase A. Neurotrophic keratitis. Eye (Lond). 2003 Nov;17(8):989-95. doi: 10.1038/sj.eye.6700616.
- Background: PubMed 26451380Mantelli F, Nardella C, Tiberi E, Sacchetti M, Bruscolini A, Lambiase A. Congenital Corneal Anesthesia and Neurotrophic Keratitis: Diagnosis and Management. Biomed Res Int. 2015;2015:805876. doi: 10.1155/2015/805876. Epub 2015 Sep 16.
- Background: PubMed 25010775Elbaz U, Bains R, Zuker RM, Borschel GH, Ali A. Restoration of corneal sensation with regional nerve transfers and nerve grafts: a new approach to a difficult problem. JAMA Ophthalmol. 2014 Nov;132(11):1289-95. doi: 10.1001/jamaophthalmol.2014.2316.
- Background: PubMed 19116544Terzis JK, Dryer MM, Bodner BI. Corneal neurotization: a novel solution to neurotrophic keratopathy. Plast Reconstr Surg. 2009 Jan;123(1):112-120. doi: 10.1097/PRS.0b013e3181904d3a.
- Background: PubMed 28570404Sepehripour S, Lloyd MS, Nishikawa H, Richard B, Parulekar M. Surrogate Outcome Measures for Corneal Neurotization in Infants and Children. J Craniofac Surg. 2017 Jul;28(5):1167-1170. doi: 10.1097/SCS.0000000000003677.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal neurotization in people with Neurotrophic Corneal Ulcer and Neurotrophic Keratitis, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Apr 2023. 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 States. 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?
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal sensation (time frame: Baseline (pre-operative) to 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809245, which also lists 6 linked publications.
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 12 Apr 2023.