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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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ClinicalTrials.gov Identifier: NCT01809483
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Sponsor:
Information provided by (Responsible Party):
Ni Nyoman Triharpini, 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.

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain scale [ Time Frame: 24 hour ]
    Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively


Other Outcome Measures:
  1. Complication [ Time Frame: 24 hour ]
    Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)



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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809483


Locations
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Indonesia
Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital
Denpasar, Bali, Indonesia, 80114
Sponsors and Collaborators
Udayana University
Investigators
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Principal Investigator: Ni Nyoman Triharpini, MD Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital

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Responsible Party: Ni Nyoman Triharpini, Resident in Depatment of Ophthalmology Faculty of Medicine, Udayana University
ClinicalTrials.gov Identifier: NCT01809483     History of Changes
Other Study ID Numbers: LB0201/IIC5D11/16095/2012
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Ni Nyoman Triharpini, Udayana University:
mechanical corneal erosion
bandage contact lens
pressure patching
erosion area
pain scale

Additional relevant MeSH terms:
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Corneal Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases