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Outcome Measures

Primary Outcomes (1)

Corneal epithelial wound healing
Patients were examined on post-operative days 1, 2, 3, 5, and 7, or until complete epithelization in both eyes. During these visits, the bandage contact lens were removed and the size of the epithelial defect was measured (guided by fluorescein staining) at its greatest dimension, along two perpendicular axes with a slit lamp micrometer. The healing rate, which is the speed at which the corneal epithelium heals, was assessed. It involved measuring the epithelial defect size changes over time by calculating the percentage of epithelial defect closure: (Original epithelial defect area - Current epithelial defect area)/(Current epithelial defect area) x 100. The percentage was calculated at each visit by the same examiner. New bandage contact lenses were applied after each examination until complete epithelial healing was achieved.
7 days or until complete epithelial healing

Secondary Outcomes (1)

Post-operative pain
7 days or until complete epithelial healing

Study Arms (2)

Insulin eye drops

EXPERIMENTAL

After bilateral sequential corneal cross-linking, each patient had one eye randomly assigned to receive insulin eye drops (4 times daily until complete epithelization) in addition to the standard post-operative treatment which was prescribed to both eyes (bandage contact lenses, Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily). Insulin eye drops were prepared by adding 10 IU of human insulin (Actrapid; Novo Nordisk, Denmark) to 10 mL of Systane Hydration, yielding a 1 IU/mL solution. Patients were instructed to keep the drops refrigerated. Randomization was done using a coin toss (heads = right eye, tails = left eye) performed after eligibility confirmation, with allocation concealed using sequentially numbered, sealed envelopes prepared before recruitment.

Drug: Insulin eye drops

Standard post-operative treatment only

ACTIVE COMPARATOR

The other eye (control) of the same patient received the standard post-operative treatment only. This treatment included bandage contact lenses (1-Day Acuvue Moist, -0.25 D; Johnson \& Johnson Vision Care, USA), Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily.

Interventions

Insulin eye dropsDrug

A paired-eye interventional study exploring the effect of insulin eye drops on corneal epithelial wound healing after corneal collagen cross-linking in Keratoconus patients. Each patient served as their own control, where on eye received insulin eye drops post-operatively while the fellow eye (control) didn't.

Insulin eye drops

standard post-operative topical dropsDrug

The standard post-operative treatment prescribed to both eyes included Moxifloxacin 0.5% (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily.

Study Design

Study Type

interventional

Phase

phase 2 3

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: This is a paired-eye study, patients with bilateral progressive keratoconus were scheduled for corneal collagen cross-linking in both eyes at the same day. Post-operatively, each patient had one eye randomly assigned to receive insulin eye drops in addition to the standard post-operative treatment (antibiotic eye drops 4 times daily, steroid eye drops 4 times daily and preservative free-tear substitutes 4 times daily), while the other eye received the standard treatment alone (control).

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

PhD candidate, Cairo University Faculty of Medicine

Insulin Eye Drops and Epithelial Healing After Corneal Cross-linking

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Insulin eye drops

Standard post-operative treatment only

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Insulin eye drops

Standard post-operative treatment only

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations