Recruiting

Bandage Contact Lens & Patching

Sponsor:

University Health Network, Toronto

Code:

NCT01249235

Conditions

Pterygium

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Patch or bandage contact lens

Study Details

Brief summary:

The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.

Conditions

Pterygium

Study ID

NCT01249235

Start date

Oct, 2010

Status verified date

Oct, 2010

Completion date

Oct, 2011

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
  • Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
  • Ability to understand the nature of the procedure and to complete all measurement requirements
  • Adults (age greater than 18)

Exclusion Criteria:

  • Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
  • Patients who have had previous ocular surface surgery
  • Contraindications to local anesthetics (such as known allergy)
  • Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
  • Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
  • Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Patch

The operative eye will be patched.

experimental: Bandage Contact Lens

The operative eye will have a bandage contact lens

Interventions

Patch or bandage contact lens

Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.

Primary outcome measure

  • Visual Analog Pain Score [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Allan Slomovic, MD

allan.slomovic@utoronto.ca

Locations

Toronto Western Hospital, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Sonia Yeung, MD

sonia.yeung@utoronto.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 29, 2010

Last verified

Oct, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2010-11-29.