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

December 14, 2010 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital, University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Superior Conjunctival Autograft
Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue.
Procedure: Location of the autograft taken following pterygium excision
Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.
Experimental: Inferior Conjunctival Autograft
Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue.
Procedure: Location of the autograft taken following pterygium excision
Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time taken to complete the surgical procedure (minutes)
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

December 14, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB-09-0999A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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