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

NCT ID: NCT01261455

Last Updated: 2010-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

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.

Detailed Description

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Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Superior Conjunctival Autograft

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

Group Type ACTIVE_COMPARATOR

Location of the autograft taken following pterygium excision

Intervention Type PROCEDURE

Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.

Inferior Conjunctival Autograft

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

Group Type EXPERIMENTAL

Location of the autograft taken following pterygium excision

Intervention Type PROCEDURE

Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.

Interventions

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Location of the autograft taken following pterygium excision

Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.

Intervention Type PROCEDURE

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

Exclusion Criteria

* Adults (age \>18)


* 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)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University of Toronto

Principal Investigators

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Allan Slomovic, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hospital, University of Toronto

Locations

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Toronto Western Hospital, University of Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Allan Slomovic, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sonia Yeung, MD

Role: primary

Other Identifiers

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REB-09-0999A

Identifier Type: -

Identifier Source: org_study_id