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

University Health Network, Toronto

Status: Unknown

Conditions: Pterygium

Treatments: Procedure: Location of the autograft taken following pterygium excision

Study type: Interventional

Funder types: Other

Identifiers

NCT01261455

REB-09-0999A

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Superior Conjunctival Autograft

Active Comparator group

Description:

Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue.

Treatment:

Procedure: Location of the autograft taken following pterygium excision

Inferior Conjunctival Autograft

Experimental group

Description:

Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue.

Treatment:

Procedure: Location of the autograft taken following pterygium excision