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Completed

NCT Number: NCT01809483

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

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.

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Key information

Conditions

Erosion; Cornea, Traumatic Corneal Diseases Eye Diseases

Age range

17 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Denpasar, Bali, 80114, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bandage contact lens

Device

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

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.

Primary outcomes

  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 outcomes

  1. Pain scale

    Time frame: 24 hour

    Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively

Other outcomes

  1. Complication

    Time frame: 24 hour

    Complication of corneal erosion (e.g. conjunctivitis, keratitis, corneal ulcer)

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2013
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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