NCT05809245

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

May 14, 2018

Last Update Submit

March 29, 2023

Conditions

Neurotrophic Corneal UlcerNeurotrophic KeratitisCranial Nerve V Diseases

Keywords

Corneal neurotizationneurotrophic corneaneurotrophic corneal ulcer

Outcome Measures

Primary Outcomes (1)

  • Corneal sensation

    Corneal sensation will be measured via Cochet Bonnet esthesiometry

    Baseline (pre-operative) to 12 months postoperatively

Secondary Outcomes (2)

  • Visual acuity

    Baseline (pre-operative) to 12 months postoperatively

  • Corneal opacity

    Baseline (pre-operative) to 12 months postoperatively

Study Arms (1)

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.

Procedure: Corneal neurotization

Interventions

Corneal neurotizationPROCEDURE

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.

Corneal neurotization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with neurotrophic cornea

You may not qualify if:

  • Patients with history of penetrating keratoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea Kossler

Palo Alto, California, 94303, United States

Location

Related Publications (6)

  • 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.

    PMID: 17212990BACKGROUND

  • Bonini S, Rama P, Olzi D, Lambiase A. Neurotrophic keratitis. Eye (Lond). 2003 Nov;17(8):989-95. doi: 10.1038/sj.eye.6700616.

    PMID: 14631406BACKGROUND

  • Mantelli 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.

    PMID: 26451380BACKGROUND

  • Elbaz 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.

    PMID: 25010775BACKGROUND

  • Terzis 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.

    PMID: 19116544BACKGROUND

  • Sepehripour 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.

    PMID: 28570404BACKGROUND

MeSH Terms

Conditions

Trigeminal Nerve Diseases

Condition Hierarchy (Ancestors)

Facial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Oculoplastic Surgery & Orbital Oncology Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

May 14, 2018

First Posted

April 12, 2023

Study Start

March 15, 2018

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)