Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

Not Applicable

• Conditions: Pterygium
• Interventions: Procedure: Patch or bandage contact lens

• Registration Number: NCT01249235
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Primary Completion: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-24
• Last Update Submitted: 2010-11-24
• Study First Posted: 2010-11-29
• Last Update Posted: 2010-11-29
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patch	Patch or bandage contact lens	The operative eye will be patched.
Bandage Contact Lens	Patch or bandage contact lens	The operative eye will have a bandage contact lens

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Score	1 week

Secondary Outcome Measures

Name	Time	Method
Sensitivity to light, tearing, foreign body sensation	1 week
Postoperative Complications	1 week	Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation
Number of Tylenol #3 tablets required	1 week

Trial Locations

Locations (1)

Toronto Western Hospital, University of Toronto; 🇨🇦 Toronto, Ontario, Canada