Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809245
Status:
TERMINATED
Last Update Posted:
2023-04-12
First Post:
2018-05-14
Brief Title:
Corneal Neurotization as a Treatment for Neurotrophic Keratopathy
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Corneal Neurotization Via Sural Nerve Transfer or Cadaveric Nerve Graft for Neurotrophic Keratopathy
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 treatment1-3 Neurotization is a revolutionary technique reported to restore corneal sensation in neurotrophic keratopathy4-6 Prior techniques described include direct neurotization with contralateral supraorbital and supratrochlear nerves accessed via a bicoronal incision of the scalp over the forehead5 nerve grafting with contralateral supratrochlear nerves accessed via a medial upper eyelid incision6 and sural nerve grafting to contralateral supratrochlear nerves accessed via a transverse incision over the medial upper eyelid4 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None