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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

Page last updated: August 23, 2015

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