Corneal Neurotization as a Treatment for Neurotrophic Keratopathy

Not Applicable

Terminated

• Conditions: Neurotrophic Keratitis; Neurotrophic Corneal Ulcer; Cranial Nerve V Diseases
• Interventions: Procedure: Corneal neurotization

• Registration Number: NCT05809245
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-05-14
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients with neurotrophic cornea

Exclusion Criteria

• Patients with history of penetrating keratoplasty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Corneal neurotization	Corneal neurotization	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.

Primary Outcome Measures

Name	Time	Method
Corneal sensation	Baseline (pre-operative) to 12 months postoperatively	Corneal sensation will be measured via Cochet Bonnet esthesiometry

Secondary Outcome Measures

Name	Time	Method
Corneal opacity	Baseline (pre-operative) to 12 months postoperatively	Measured based on grade 0-4 based on degree of opacity.
Visual acuity	Baseline (pre-operative) to 12 months postoperatively	Measurement using Snellen eye chart

Trial Locations

Locations (1)

Andrea Kossler; 🇺🇸 Palo Alto, California, United States