Corneal Neurotization as a Treatment for Neurotrophic Keratopathy

March 29, 2023 updated by: Andrea L Kossler, Stanford University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Andrea Kossler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with neurotrophic cornea

Exclusion Criteria:

  • Patients with history of penetrating keratoplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Corneal neurotization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal sensation
Time Frame: Baseline (pre-operative) to 12 months postoperatively
Corneal sensation will be measured via Cochet Bonnet esthesiometry
Baseline (pre-operative) to 12 months postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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