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

Not Applicable

• Conditions: Pterygium
• Interventions: Procedure: Location of the autograft taken following pterygium excision

• Registration Number: NCT01261455
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-12-14
• Last Update Submitted: 2010-12-14
• Study First Posted: 2010-12-16
• Last Update Posted: 2010-12-16
• Primary Completion: 2011-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Superior Conjunctival Autograft	Location of the autograft taken following pterygium excision	Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue.
Inferior Conjunctival Autograft	Location of the autograft taken following pterygium excision	Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue.

Primary Outcome Measures

Name	Time	Method
Time taken to complete the surgical procedure (minutes)	1 year

Secondary Outcome Measures

Name	Time	Method
Visual Analog Pain Score	1 week
Recurrence of pterygium	1 year
Intraoperative and Postoperative Complications	6 months

Trial Locations

Locations (1)

Toronto Western Hospital, University of Toronto; 🇨🇦 Toronto, Ontario, Canada