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Clinical Trials/NCT01809483
NCT01809483
Completed
Phase 3

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

Udayana University1 site in 1 country32 target enrollmentSeptember 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Erosion; Cornea, Traumatic
Sponsor
Udayana University
Enrollment
32
Locations
1
Primary Endpoint
Size of corneal erosion area
Status
Completed
Last Updated
13 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
February 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Ni Nyoman Triharpini

Resident in Depatment of Ophthalmology Faculty of Medicine

Udayana University

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

Outcomes

Primary Outcomes

Size of corneal erosion area

Time Frame: 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 Outcomes

  • Pain scale(24 hour)

Study Sites (1)

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