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

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01261455
• Other study ID #: REB-09-0999A
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: December 14, 2010
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2010
• Source: University Health Network, Toronto
• Contact: Allan Slomovic, MD
• Email: allan.slomovic[@]utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• Location of the autograft taken following pterygium excision
Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken to complete the surgical procedure (minutes)		1 year	No
Secondary	Visual Analog Pain Score		1 week	No
Secondary	Recurrence of pterygium		1 year	No
Secondary	Intraoperative and Postoperative Complications		6 months	Yes