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

University Health Network, Toronto

Status: Unknown

Conditions: Pterygium

Treatments: Procedure: Patch or bandage contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT01249235

REB-10-0538

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patch

Active Comparator group

Description:

The operative eye will be patched.

Treatment:

Procedure: Patch or bandage contact lens

Bandage Contact Lens

Experimental group

Description:

The operative eye will have a bandage contact lens

Treatment:

Procedure: Patch or bandage contact lens