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

NCT01261455 | Unknown DMC

• 1 other identifier: REB-09-0999A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time taken to complete the surgical procedure (minutes)

  1 year

Secondary Outcomes (3)

• Visual Analog Pain Score

  1 week

• Recurrence of pterygium

  1 year

• Intraoperative and Postoperative Complications

  6 months

Study Arms (2)

Superior Conjunctival Autograft

ACTIVE COMPARATOR

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

Procedure: Location of the autograft taken following pterygium excision

Inferior Conjunctival Autograft

EXPERIMENTAL

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

Procedure: Location of the autograft taken following pterygium excision

Interventions

Location of the autograft taken following pterygium excision PROCEDURE

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

Inferior Conjunctival Autograft; Superior Conjunctival Autograft

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adults (age \>18)
• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University of Toronto

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Officials

• Allan Slomovic, MD

  Toronto Western Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Slomovic, MD

CONTACT

allan.slomovic@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 16, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 16, 2010

Record last verified: 2010-10

Locations

CA (1)