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

Primary Purpose

Pterygium

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Patch or bandage contact lens

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Toronto Western Hospital, University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patch

Bandage Contact Lens

Arm Description

The operative eye will be patched.

The operative eye will have a bandage contact lens

Outcomes

Primary Outcome Measures

Visual Analog Pain Score

Secondary Outcome Measures

Sensitivity to light, tearing, foreign body sensation

Postoperative Complications

Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation

Number of Tylenol #3 tablets required

Full Information

NCT ID

NCT01249235

First Posted

November 22, 2010

Last Updated

November 24, 2010

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01249235

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pterygium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patch

Arm Type

Active Comparator

Arm Description

The operative eye will be patched.

Arm Title

Bandage Contact Lens

Arm Type

Experimental

Arm Description

The operative eye will have a bandage contact lens

Intervention Type

Procedure

Intervention Name(s)

Patch or bandage contact lens

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analog Pain Score

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Sensitivity to light, tearing, foreign body sensation

Time Frame

1 week

Title

Postoperative Complications

Description

Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation

Time Frame

1 week

Title

Number of Tylenol #3 tablets required

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allan Slomovic, MD

allan.slomovic@utoronto.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan Slomovic, MD

Organizational Affiliation

Toronto Western Hospital, University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Western Hospital, University of Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonia Yeung, MD

sonia.yeung@utoronto.ca

12. IPD Sharing Statement

Learn more about this trial

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

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