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

NCT01249235 | Unknown

• 1 other identifier: REB-10-0538
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Score

  1 week

Secondary Outcomes (3)

• Sensitivity to light, tearing, foreign body sensation

  1 week

• Postoperative Complications

  1 week

• Number of Tylenol #3 tablets required

  1 week

Study Arms (2)

Patch

ACTIVE COMPARATOR

The operative eye will be patched.

Procedure: Patch or bandage contact lens

Bandage Contact Lens

EXPERIMENTAL

The operative eye will have a bandage contact lens

Procedure: Patch or bandage contact lens

Interventions

Patch or bandage contact lens PROCEDURE

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

Bandage Contact Lens; Patch

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University of Toronto

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pterygium

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Allan Slomovic, MD

  Toronto Western Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Slomovic, MD

CONTACT

allan.slomovic@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 29, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: November 29, 2010

Record last verified: 2010-10

Locations

CA (1)