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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01261455
First received: November 22, 2010
Last updated: December 14, 2010
Last verified: October 2010
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analog Pain Score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Recurrence of pterygium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intraoperative and Postoperative Complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Allan Slomovic, University of Toronto
ClinicalTrials.gov Identifier: NCT01261455     History of Changes
Other Study ID Numbers: REB-09-0999A
Study First Received: November 22, 2010
Last Updated: December 14, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 19, 2014