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

Erosion; Cornea, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809483
• Other study ID #: LB0201/IIC5D11/16095/2012
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2013
• Last updated: March 8, 2013
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Udayana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Corneal Ulcer
• Erosion; Cornea, Traumatic

Intervention

Device:
• Bandage contact lens
Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)
• 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.

Locations

Country	Name	City	State
Indonesia	Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication	Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)	24 hour
Primary	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	24 hour
Secondary	Pain scale	Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively	24 hour