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

April 24, 2021 updated by: Dr. Ricardo Machado Soares, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

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

  • Portugal
      • Vila Nova de Gaia, Portugal
        • Centro Hospitalar Vila Nova de Gaia e Espinho

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

Genders Eligible for Study

All

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.

Description

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.

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days until closure of the corneal wound
Time Frame: Time until complete resolution of corneal wound, assessed up to 8 weeks
Days
Time until complete resolution of corneal wound, assessed up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected Visual Acuity improvement
Time Frame: Before and after treatment completion, assessed up to 8 weeks
logMAR
Before and after treatment completion, assessed up to 8 weeks

Collaborators and Investigators

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

Sponsor

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

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

Helpful Links

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)

October 1, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

March 20, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 24, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12776388755f18199947f

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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