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

NCT04820010 | Completed DMC

• 1 other identifier: 12776388755f18199947f
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Ulcer; Corneal Perforation; Corneal Epithelium Defect; Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (1)

• Days until closure of the corneal wound

  Days

  Time until complete resolution of corneal wound, assessed up to 8 weeks

Secondary Outcomes (1)

• Best-corrected Visual Acuity improvement

  Before and after treatment completion, assessed up to 8 weeks

Interventions

Topical Insulin DRUG

Patients were administered eyedrops enriched with insulin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia e Espinho

Vila Nova de Gaia, Portugal

Location

Related Publications (1)

• Soares RJDSM, Arede C, Sousa Neves F, da Silva Fernandes J, Cunha Ferreira C, Sequeira J. Topical Insulin-Utility and Results in Refractory Neurotrophic Keratopathy in Stages 2 and 3. Cornea. 2022 Aug 1;41(8):990-994. doi: 10.1097/ICO.0000000000002858. Epub 2021 Sep 3.

  PMID: 34483270 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Corneal Ulcer; Corneal Perforation

Interventions

Insulin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases; Corneal Injuries; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 29, 2021
• Study Start: October 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

PT (1)