Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. The investigators will also be recording the level of pain felt by patients after surgery, any difficulties during or after surgery, and if the pterygium grows back.

Official Title
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Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Location of the autograft taken following pterygium excision


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 Ability to understand the nature of the procedure and to complete all measurement requirements Patients must be eligible for either the superior or inferior conjunctival autografts (they must not meet any of the following exclusion criteria) Adults (age >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 Patients with glaucoma or those who may need glaucoma surgery in the future 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)

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: Superior Conjunctival Autograft<br>Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue. | Procedure: Location of the autograft taken following pterygium excision<br>* Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.<br>|
| Experimental: Inferior Conjunctival Autograft<br>Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue. | Procedure: Location of the autograft taken following pterygium excision<br>* Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to complete the surgical procedure (minutes) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Score |  | 1 week | 
| Recurrence of pterygium |  | 1 year | 
| Intraoperative and Postoperative Complications |  | 6 months |