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

Sponsor

Udayana University (Other)

Overall Status

Completed

CT.gov ID

NCT01809483

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erosion; Cornea, Traumatic	Device: Bandage contact lens Device: Pressure patching	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bandage contact lens group 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 Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)
Active Comparator: Pressure patching group 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 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.

Arm

Intervention/Treatment

Experimental: Bandage contact lens group

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

Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)

Active Comparator: Pressure patching group

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

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.

Outcome Measures

Primary Outcome Measures

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

Pain scale [24 hour]
Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively

Other Outcome Measures

Complication [24 hour]
Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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