Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Information source: Udayana University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erosion; Cornea, Traumatic
Intervention: Bandage contact lens (Device); Pressure patching (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Udayana University Official(s) and/or principal investigator(s): Ni Nyoman Triharpini, MD, Principal Investigator, Affiliation: Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital
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.
Clinical Details
Official title: Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Size of corneal erosion area
Secondary outcome: Pain scale
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
Eligibility
Minimum age: 17 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital, Denpasar, Bali 80114, Indonesia
Additional Information
Starting date: September 2012
Last updated: March 8, 2013
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