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Clinical Trials/NCT01249235
NCT01249235
Unknown
Not Applicable

Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

University Health Network, Toronto1 site in 1 country60 target enrollmentOctober 2010
ConditionsPterygium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pterygium
Sponsor
University Health Network, Toronto
Enrollment
60
Locations
1
Primary Endpoint
Visual Analog Pain Score
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
October 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Visual Analog Pain Score

Time Frame: 1 week

Secondary Outcomes

  • Sensitivity to light, tearing, foreign body sensation(1 week)
  • Postoperative Complications(1 week)
  • Number of Tylenol #3 tablets required(1 week)

Study Sites (1)

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