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

Primary Purpose

Erosion; Cornea, Traumatic

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Bandage contact lens
Pressure patching
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosion; Cornea, Traumatic focused on measuring mechanical corneal erosion, bandage contact lens, pressure patching, erosion area, pain scale

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bandage contact lens group

Pressure patching group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain scale
Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively

Full Information

First Posted
March 8, 2013
Last Updated
March 8, 2013
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT01809483
Brief Title
Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Official Title
Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosion; Cornea, Traumatic
Keywords
mechanical corneal erosion, bandage contact lens, pressure patching, erosion area, pain scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bandage contact lens group
Arm Type
Experimental
Arm Description
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
Arm Title
Pressure patching group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bandage contact lens
Intervention Description
Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)
Intervention Type
Device
Intervention Name(s)
Pressure patching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Size of corneal erosion area
Description
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
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Pain scale
Description
Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively
Time Frame
24 hour
Other Pre-specified Outcome Measures:
Title
Complication
Description
Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ni Nyoman Triharpini, MD
Organizational Affiliation
Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia

12. IPD Sharing Statement

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

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