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

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.

Study Overview

• Status: Completed
• Conditions: Erosion; Cornea, Traumatic
• Intervention / Treatment: Device: Bandage contact lens; Device: Pressure patching

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)	24 hour

Collaborators and Investigators

• Sponsor: Udayana University
• Investigators: Principal Investigator: Ni Nyoman Triharpini, MD, Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: March 8, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (ESTIMATE): March 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 8, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: bandage contact lens; pain scale; mechanical corneal erosion; pressure patching; erosion area
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Keratitis; Corneal Diseases; Eye Infections; Corneal Ulcer
• Other Study ID Numbers: LB0201/IIC5D11/16095/2012