Recruiting

Inferior vs. Superior

Sponsor:

University Health Network, Toronto

Code:

NCT01261455

Conditions

Pterygium

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Location of the autograft taken following pterygium excision

Study Details

Brief summary:

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.

Conditions

Pterygium

Study ID

NCT01261455

Start date

Oct, 2010

Status verified date

Oct, 2010

Completion date

Oct, 2012

Anticipated

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Superior Conjunctival Autograft

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

experimental: Inferior Conjunctival Autograft

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

Interventions

Location of the autograft taken following pterygium excision

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Allan Slomovic, MD

allan.slomovic@utoronto.ca

Locations

Toronto Western Hospital, University of Toronto

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Sonia Yeung, MD

sonia.yeung@utoronto.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 16, 2010

Last verified

Oct, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2010-12-16.