Clinical trial

Efficacy and Safety of Topical Insulin in Acute-onset Neurotrophic Keratopathy After Diabetic Vitrectomy

Name

RC-7-2023

Description

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.

Trial arms

Trial start

2023-07-15

Estimated PCD

2023-08-01

Trial end

2023-08-15

Status

Not yet recruiting

Treatment

rapid acting insulin

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.

Arms:

Study

Size

Primary endpoint

time to epithelial healing

4 weeks

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-07-11

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication