Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy

NCT05940376 | Unknown DMC FDA Drug

• 1 other identifier: RC-7-2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Various treatment options have been proposed in managing NK such as preservative-free lubrication (PF-L), withdrawal of epitheliotoxic medication, prophylactic antibiotics, applying of bandage contact lenses, using hemoderivatives 8, topical insulin, recombinant nerve growth factor (rNGF) or epidermal growth factor (rEGF).11,12, amniotic membrane transplant (AMT), or corneal neurotization.2,4,9,10 Topical insulin has been reported to effectively promote the healing of persistent corneal epithelial defects. In our retrospective study, we explored the safety and efficacy of topical insulin, as a first-line treatment, in treatment-naïve acute NK after diabetic vitrectomy.

Conditions

Corneal Ulcer; Neurotrophic Corneal Ulcer; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• time to epithelial healing

  healed ulcer is defined as \<0.5 mm of fluorescein staining in the greatest dimension of the lesion area.

  4 weeks

Secondary Outcomes (1)

• any adverse effect of topical insulin or need for amniotic membrane transplantation

  8 weeks

Study Arms (2)

Control

Group A was assigned to receive preservative-free lubricants and prophylactic antibiotics.

Study

Group B was assigned to receive topical insulin \[1 unit per drop\] 4 times per day (QID) in addition to previous treatment.

Drug: rapid acting insulin

Interventions

rapid acting insulin DRUG

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 (2°C) and, was provided by the cornea specialist and was self-administered by patients at a dosage of 1 eye drop 4 times daily. Treatment continued until NK healed and then tapered accordingly. Patients would discontinue topical insulin if the condition did not improve or worsen within 4 weeks. Patients were followed up daily and slit-lamp photographs were captured with and without fluorescein corneal staining.

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult diabetic patients (18 years of age) with neurotrophic keratopathy developing within 21 days after diabetic vitrectomy.

You may qualify if:

• Adult diabetic patients (18 years of age) with neurotrophic keratopathy developing within 21 days after diabetic vitrectomy. NK was classified as stage 1 (epithelial changes only without epithelial defect), stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) according to published criteria.
• decreased corneal sensitivity within the corneal lesion and in at least 1 corneal quadrant outside the lesion.

You may not qualify if:

• Those patients who needed intraoperative epithelial debridement during vitrectomy, having past history of ocular surgeries other than cataract surgery, or history of herpetic eye disease or limbal stem cell deficiency were excluded.
• active ocular infection or inflammation unrelated to neurotrophic keratopathy, lagophthalmos, and other ocular disease or severe vision loss in the affected eye(s).

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, 13512, Egypt

Location

Related Publications (2)

• 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 RESULT

• Galvis V, Nino CA, Tello A, Grice JM, Gomez MA. Topical insulin in neurotrophic keratopathy after resection of acoustic neuroma. Arch Soc Esp Oftalmol (Engl Ed). 2019 Feb;94(2):100-104. doi: 10.1016/j.oftal.2018.06.003. Epub 2018 Jul 17. English, Spanish.

  PMID: 30025986 RESULT

MeSH Terms

Conditions

Corneal Ulcer; Diabetes Mellitus

Interventions

Insulin, Short-Acting

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Taher Kamel Mahmoud Hussein Eleiwa, MD PhD

CONTACT

01069901973; tahereleiwa87@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 11, 2023
• Study Start: July 15, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 15, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)