We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by University Health Network, Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01261455
First Posted: December 16, 2010
Last Update Posted: December 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose
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.

Condition Intervention
Pterygium Procedure: Location of the autograft taken following pterygium excision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Time taken to complete the surgical procedure (minutes) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Visual Analog Pain Score [ Time Frame: 1 week ]
  • Recurrence of pterygium [ Time Frame: 1 year ]
  • Intraoperative and Postoperative Complications [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261455


Contacts
Contact: Allan Slomovic, MD allan.slomovic@utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital, University of Toronto Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Sonia Yeung, MD       sonia.yeung@utoronto.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Allan Slomovic, MD Toronto Western Hospital, University of Toronto
  More Information

Responsible Party: Allan Slomovic, University of Toronto
ClinicalTrials.gov Identifier: NCT01261455     History of Changes
Other Study ID Numbers: REB-09-0999A
First Submitted: November 22, 2010
First Posted: December 16, 2010
Last Update Posted: December 16, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases