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

Study Overview
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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.

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

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Patch or bandage contact lens


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patch<br>The operative eye will be patched. | Procedure: Patch or bandage contact lens<br>* Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.<br>|
| Experimental: Bandage Contact Lens<br>The operative eye will have a bandage contact lens | Procedure: Patch or bandage contact lens<br>* Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity to light, tearing, foreign body sensation |  | 1 week | 
| Postoperative Complications | Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation | 1 week | 
| Number of Tylenol #3 tablets required |  | 1 week |