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

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249235
• Other study ID #: REB-10-0538
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: November 24, 2010
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2010
• Source: University Health Network, Toronto
• Contact: Allan Slomovic, MD
• Email: allan.slomovic[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Score		1 week	No
Secondary	Sensitivity to light, tearing, foreign body sensation		1 week	No
Secondary	Postoperative Complications	Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation	1 week	Yes
Secondary	Number of Tylenol #3 tablets required		1 week	No