Corneal UlcerNCT04820010
Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
An observational study of Corneal Ulcer and Corneal Perforation, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Ulcer, Corneal Perforation, Corneal Epithelium Defect
- What is being tested?
- Topical Insulin
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2018to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Established diagnosis of NK in stages 2 or 3 refractory to standard treatment that underwent topical insulin treatment.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Vila Nova de Gaia e Espinho
Vila Nova de Gaia
About this study
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.
Read the 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.
- Being tested
- Topical Insulin
- Medical subject headings
- Corneal Ulcer, Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical InsulinDrug
Patients were administered eyedrops enriched with insulin
What is being measured
The primary outcome is the main question the study is designed to answer.
Days until closure of the corneal wound
Days
Measured: Time until complete resolution of corneal wound, assessed up to 8 weeks
Secondary outcomes (1)
Best-corrected Visual Acuity improvement
logMAR
Measured: Before and after treatment completion, assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Oct 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ricardo Machado Soares, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820010
- Sponsor's protocol ID
- 12776388755f18199947f
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34483270
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin - Utility and Results in Neurotrophic Keratopathy in Stages 2 and 3
- ClinicalTrials.gov ID
- NCT04820010
- Acronym / sponsor ID
- 12776388755f18199947f
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Other government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Established diagnosis of NK in stages 2 or 3 refractory to standard treatment that underwent topical insulin treatment.
Key inclusion criteria (7 listed)
- Eyes with established diagnosis of NK in stages 2 or 3 refractory to standard treatment* that underwent topical insulin treatment.
- 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;
- We excluded every patient with corneal ulcer and signs of infection.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical InsulinPatients were administered eyedrops enriched with insulin | Drug | – |
Primary outcome
Days until closure of the corneal wound
Time frame: Time until complete resolution of corneal wound, assessed up to 8 weeks
Days
1 secondary outcome
Best-corrected Visual Acuity improvement
Time frame: Before and after treatment completion, assessed up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 34483270Soares 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.
- Related InfoLink provided by the sponsor.
Related trials for Corneal Ulcer
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
RecruitingPhase 3
Parasitic Ulcer Treatment Trial
Acanthamoeba Keratitis
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Not yet recruitingPhase 2
Fluorometholone Study
Keratitis Bacterial, Corneal Ulcer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ulcer and Corneal Perforation, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days until closure of the corneal wound (time frame: Time until complete resolution of corneal wound, assessed up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04820010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.