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

Phase 3

Completed

• Conditions: Erosion; Cornea, Traumatic
• Interventions: Device: Bandage contact lens; Device: Pressure patching

• Registration Number: NCT01809483
• Lead Sponsor: Udayana University

Brief Summary

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

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

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Last Update Submitted: 2013-03-08
• Study First Posted: 2013-03-12
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bandage contact lens group	Bandage contact lens	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
Pressure patching group	Pressure patching	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

Primary Outcome Measures

Name	Time	Method
Size of corneal erosion area	24 hour	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

Secondary Outcome Measures

Name	Time	Method
Pain scale	24 hour	Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively

Trial Locations

Locations (1)

Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital; 🇮🇩 Denpasar, Bali, Indonesia