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

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Location of the autograft taken following pterygium excision
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Toronto Western Hospital, University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Superior Conjunctival Autograft

Inferior Conjunctival Autograft

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time taken to complete the surgical procedure (minutes)

Secondary Outcome Measures

Visual Analog Pain Score
Recurrence of pterygium
Intraoperative and Postoperative Complications

Full Information

First Posted
November 22, 2010
Last Updated
December 14, 2010
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01261455
Brief Title
Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
Official Title
Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Superior Conjunctival Autograft
Arm Type
Active Comparator
Arm Description
Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue.
Arm Title
Inferior Conjunctival Autograft
Arm Type
Experimental
Arm Description
Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue.
Intervention Type
Procedure
Intervention Name(s)
Location of the autograft taken following pterygium excision
Intervention Description
Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.
Primary Outcome Measure Information:
Title
Time taken to complete the surgical procedure (minutes)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual Analog Pain Score
Time Frame
1 week
Title
Recurrence of pterygium
Time Frame
1 year
Title
Intraoperative and Postoperative Complications
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Slomovic, MD
Email
allan.slomovic@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Slomovic, MD
Organizational Affiliation
Toronto Western Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Yeung, MD
Email
sonia.yeung@utoronto.ca

12. IPD Sharing Statement

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

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