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Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04820010
Recruitment Status : Completed
First Posted : March 29, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Ricardo Machado Soares, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Study Description
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Brief Summary:

Purpose: To evaluate the clinical outcome of patients with refractory Neurotrophic Keratopathy (NK) in stages 2 and 3 treated with topical insulin.

Methods: A retrospective, observational analysis of eyes with NK in stages 2 and 3 refractory to standard medical and/or surgical treatment which were treated with topical insulin. Topical insulin (1 unit per mL) was applied 4 times a day; treatment was continued until persistent epithelial defect (PED) or ulcer resolved and then tapered accordingly. The primary outcome of the study was the complete resolution of the PED or ulcer. Best-corrected visual acuity (BCVA), days until complete resolution as well as anterior segment photographs were obtained.


Condition or disease Intervention/treatment
Corneal Ulcer Corneal Perforation Corneal Epithelium Defect Neurotrophic Keratitis Drug: Topical Insulin

Detailed Description:

Study type

Retrospective, observational, single-center study at the Department of Ophthalmology of Centro Hospitalar Vila Nova de Gaia e Espinho, EPE.

Data was obtained from patients' medical records and anterior segment photographs from October 1, 2018 to November 1, 2020.

Each participant and/or relative was given a detailed explanation and a written informed consent regarding possible alternatives, risks and benefits of off-label use of topical insulin drops. This study was approved by the board of Centro Hospitalar de Vila Nova de Gaia e Espinho (UIEC-2020-981914339595fa024c567ec5). This study complied with the tenets of the Declaration of Helsinki.

Patient selection

Patients included in this study were provided from the Cornea department of the Ophthalmology center in Centro Hospitalar de Vila Nova de Gaia e Espinho. Every patient included had an established diagnosis of NK (ICD10: H16.2) in stages 2 or 3 that was refractory to standard medical and/or surgical treatment and underwent treatment with topical insulin. All patients underwent complete ophthalmological exam including best-corrected visual acuity, slit-lamp examination, corneal sensitivity in the center and four quadrants of the cornea and fundoscopic evaluation. NK was graded based on slit-lamp and fluorescein stain findings - stage 2: epithelial defect (with or without a rim of loose epithelium) without stromal ulceration; stage 3: corneal ulceration and/or stromal lysis.

Topical insulin preparation and administration

Topical insulin drops were prepared by diluting 1 unit of fast-acting insulin per 1 mL of an artificial tear with a propylene glycol base. Drops were preserved at low temperature (2ºC) and were applied four times a day. A therapeutic corneal CL was placed in every patient and fluoroquinolone drops were applied to prevent possible CL side-effects.

Treatment was continued until NK PED or Ulcer resolved and tapered accordingly. Patients would discontinue topical insulin if the condition did not improve within 30 days or worsen. Follow-up was ensured on the 3rd,5th, and 7th day and then individualized during the full-extent of treatment. Anterior segment photos were taken on each visit.

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Topical Insulin
    Patients were administered eyedrops enriched with insulin

Outcome Measures
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Primary Outcome Measures :
  1. Days until closure of the corneal wound [ Time Frame: Time until complete resolution of corneal wound, assessed up to 8 weeks ]
    Days


Secondary Outcome Measures :
  1. Best-corrected Visual Acuity improvement [ Time Frame: Before and after treatment completion, assessed up to 8 weeks ]
    logMAR


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Established diagnosis of NK in stages 2 or 3 refractory to standard treatment that underwent topical insulin treatment.
Criteria

Inclusion criteria included:

• Eyes with established diagnosis of NK in stages 2 or 3 refractory to standard treatment* that underwent topical insulin treatment.

The diagnosis of NK was based on the following criteria:

  1. Decreased or absence of corneal sensation; AND
  2. Corneal injury [PED and/or corneal ulcer] refractory to standard treatment*; AND

  3. Clinical history of conditions related to trigeminal innervation impairment;

    • Standard treatment - lubrication with artificial tears, topical and/or oral antibiotics, topical and/or oral steroids, antiviral drugs, punctal plugs, therapeutic CL, amniotic membrane surgery and temporary tarsorrhaphy.´

We excluded every patient with corneal ulcer and signs of infection.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820010


Locations
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Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho
Vila Nova de Gaia, Portugal
Sponsors and Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
More Information
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Additional Information:

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Responsible Party: Dr. Ricardo Machado Soares, MD, Principal Investigator, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
ClinicalTrials.gov Identifier: NCT04820010    
Other Study ID Numbers: 12776388755f18199947f
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Corneal Ulcer
Corneal Perforation
Keratitis
Corneal Diseases
Eye Diseases
Eye Infections
Infections
Corneal Injuries
Eye Injuries
 Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs