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

NCT01809483 | Completed Phase 3

• 1 other identifier: LB0201/IIC5D11/16095/2012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosion; Cornea, Traumatic

Keywords

mechanical corneal erosion; bandage contact lens; pressure patching; erosion area; pain scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain scale

  24 hour

Other Outcomes (1)

• Complication

  24 hour

Study Arms (2)

Bandage contact lens group

EXPERIMENTAL

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

Pressure patching group

ACTIVE COMPARATOR

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

Interventions

Bandage contact lens DEVICE

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

Bandage contact lens group

Pressure patching DEVICE

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.

Pressure patching group

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 17-55 years
• onset of corneal erosion \< 48 hours
• corneal erosion due to mechanical injury
• extensive corneal erosion \> 3 mm2

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ni Nyoman Triharpini, MD

  Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Depatment of Ophthalmology Faculty of Medicine

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

ID (1)