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Corneal Neurotization as a Treatment for Neurotrophic Keratopathy

Corneal Neurotization Via Sural Nerve Transfer or Cadaveric Nerve Graft for Neurotrophic Keratopathy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809245
Enrollment
4
Registered
2023-04-12
Start date
2018-03-15
Completion date
2020-02-12
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cranial Nerve V Diseases, Neurotrophic Corneal Ulcer, Neurotrophic Keratitis

Keywords

Corneal neurotization, neurotrophic cornea, neurotrophic corneal ulcer

Brief 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.

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.

Interventions

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with neurotrophic cornea

Exclusion criteria

* Patients with history of penetrating keratoplasty

Design outcomes

Primary

MeasureTime frameDescription
Corneal sensationBaseline (pre-operative) to 12 months postoperativelyCorneal sensation will be measured via Cochet Bonnet esthesiometry

Secondary

MeasureTime frameDescription
Visual acuityBaseline (pre-operative) to 12 months postoperativelyMeasurement using Snellen eye chart
Corneal opacityBaseline (pre-operative) to 12 months postoperativelyMeasured based on grade 0-4 based on degree of opacity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026