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

NCT ID: NCT01249235

Last Updated: 2010-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patch

The operative eye will be patched.

Group Type ACTIVE_COMPARATOR

Patch or bandage contact lens

Intervention Type PROCEDURE

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

Bandage Contact Lens

The operative eye will have a bandage contact lens

Group Type EXPERIMENTAL

Patch or bandage contact lens

Intervention Type PROCEDURE

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

Interventions

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Patch or bandage contact lens

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Toronto Western Hospital, University of Toronto

Principal Investigators

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Allan Slomovic, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital, University of Toronto

Locations

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Toronto Western Hospital, University of Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Allan Slomovic, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sonia Yeung, MD

Role: primary

Other Identifiers

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REB-10-0538

Identifier Type: -

Identifier Source: org_study_id