Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients

Study Overview
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Brief Summary
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This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

Detailed Description
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This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment

Official Title
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Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients

Conditions
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Erosion; Cornea, Traumatic

Intervention / Treatment
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* Device: Bandage contact lens
* Device: Pressure patching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 17-55 years onset of corneal erosion < 48 hours corneal erosion due to mechanical injury extensive corneal erosion > 3 mm2 Exclusion Criteria: bilateral corneal erosion corneal erosion due to chemical or thermal injury history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination history of systemic or topical antibiotics within 1 week prior to the examination other abnormalities due to trauma palpebral or eyelashes position abnormalities anterior segment infections tear break-up time < 7 seconds in the contra lateral eye

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bandage contact lens group<br>subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and bandage contact lens. Bandage contact lenses maintained for 24 hours. Antibiotic eye drops were instilled without removing the contact lenses | Device: Bandage contact lens<br>* Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)<br>|
| Active Comparator: Pressure patching group<br>Subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and pressure patching. Pressure patching maintained for 24 hours and only opened for drug application. Subject and their families were educated on how to perform a good pressure patching | Device: Pressure patching<br>* Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of corneal erosion area | Corneal erosion area is the multiplication of the long and short axis of corneal erosion, as measured using a caliper, with the help of fluorescein and cobalt blue slit lamp beam | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale | Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively | 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical corneal erosion, bandage contact lens, pressure patching, erosion area, pain scale