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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Patch or bandage contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital, University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patch; The operative eye will be patched.	Procedure: Patch or bandage contact lens; Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.
EXPERIMENTAL: Bandage Contact Lens; The operative eye will have a bandage contact lens	Procedure: Patch or bandage contact lens; Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Pain Score	1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ANTICIPATED): October 1, 2010
• Study Completion (ANTICIPATED): October 1, 2011

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 24, 2010
• First Posted (ESTIMATE): November 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 29, 2010
• Last Update Submitted That Met QC Criteria: November 24, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• Other Study ID Numbers: REB-10-0538