Corneal Epithelial Wound Healing, Post Operative Pain
Conditions
Keywords
insulin eye drops, topical insulin, corneal epithelial wound healing, paired-eye study, cross-linking, cornea, CXL
Brief summary
The goal of this clinical trial was to learn if topical insulin eye drops affected corneal epithelial wound healing after corneal collagen cross-linking. The main questions it aimed to answer were: Does topical insulin accelerate corneal epithelial healing after corneal collagen cross-linking? Does it affect post-operative pain? Participants were all diagnosed as having bilateral progressive Keratoconus and were already scheduled for bilateral cross-linking: Post-operatively, they were asked to apply insulin eye drops in one eye only (4 times daily) in addition to the prescribed routine post-operative treatment which was applied to both eyes. They were also asked to come for follow-up visits on post-operative day 1,2,3,5 and 7 or until complete corneal wound healing. The epithelial defect was measured in each eye and the participants were asked to report the degree of pain they felt in each eye at each visit until complete epithelial healing.
Interventions
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.
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients above 18 years old diagnosed with bilateral progressive Keratoconus with central corneal thickness more than 400 microns at thinnest location.
Exclusion criteria
* Patients with signs of infectious keratitis (bacterial, fungal, protozoal or mixed poly-microbial). * Patients with a history of herpetic keratitis or having diminished corneal sensation. * Patients with severe dry eye, apical corneal scarring, hydrops, a history of corneal surgery, or ophthalmic disease other than keratoconus. * Single eyed patients. * Patients on systemic treatment involving steroids or immune-compromised patients. * Patients who cannot be monitored with frequent visits as required in the study protocol. * Pregnant and nursing females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal epithelial wound healing | 7 days or until complete epithelial 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 7 days or until complete epithelial healing | At each visit, assessment of patient comfort was evaluated for each eye separately by using the Verbal Rating Scale (VRS), which consists of a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: very severe pain, 5: the worst pain ever), the patient was asked to describe the pain in each eye using these words. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORSamar A ElSaadany, MD
Cairo University
Outcome results
None listed