Comparison of Glue With Sutures for Pterygium Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Wellington Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Wellington Hospital
ClinicalTrials.gov Identifier:
NCT00326560
First received: May 15, 2006
Last updated: June 15, 2006
Last verified: May 2006
  Purpose

Pterygium excision surgery involves excising the abnormal growth from the cornea and filling the defect with a conjunctival (white of the eye) graft from the superior part of the eye. This is the best method of pterygium excision but it is recognised that in 10-15% of cases it will grow back (recurrence). Currently the investigators use small sutures to sew the graft in place. Recently it has been described that glue can be used instead of the sutures. It has been shown in one study that the patient discomfort is less and so is the surgical time. The investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. They plan to complete a prospective, randomised, control trial of 40 participants. Twenty will have traditional pterygium surgery with the conjunctival autograft sutured. Twenty will have cut and paste surgery with Tisseel glue. The two groups of participants will be compared for pain and discomfort, surgery time, and recurrence rate of the pterygia.


Condition Intervention Phase
Pterygium
Procedure: Pterygium excision and conjunctival autograft
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Cut and Paste With Sutured Autograft Pterygium Excision

Further study details as provided by Wellington Hospital:

Primary Outcome Measures:
  • Surgery time
  • Patient discomfort at day one, week one, two, four
  • Recurrence rate at months three, six, twelve

Estimated Enrollment: 40
Study Start Date: May 2006
Estimated Study Completion Date: September 2007
Detailed Description:

This is a prospective, randomised, control trial of 40 participants. Twenty patients in each arm. Twenty patients undergo standard pterygium excision with the conjunctival autograft sutured. Twenty patients undergo pterygium surgery with Tisseel glue replacing sutures as a method of attaching the conjunctival autograft. Participants will be reviewed, selected, and consented on a pre-assessment day. Surgery will be performed 10 at a time on an all day surgery operating list. Randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. One surgeon (R. Hall) will perform all of the procedures. Follow-up will occur at week 1, 2, 4, 26, 52. A questionnaire answered by participants will indicate their pain, foreign body sensation, tearing, and discomfort. There will be observation of any complications such as graft failure and recurrence rate. Photographs will be taken pre-op and post-op.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary pterygium

Exclusion Criteria:

  • Ocular surface disease
  • Previous pterygium surgery
  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: NCT00326560

Contacts
Contact: Reece C Hall, MBChB 0064 4 3855999 ext pager2566 reece.hall@ccdhb.org.nz

Locations
New Zealand
Wellington Ophthalmology Department, Capital Coast District Health Board Recruiting
Wellington, New Zealand, 6001
Contact: Reece C Hall, MBChB    0064 4 3855999 ext page2566    reece.hall@ccdhb.org.nz   
Principal Investigator: Reece C Hall, MBChB         
Sponsors and Collaborators
Wellington Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Reece C Hall, MBChB Capital Coast District Health Board
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00326560     History of Changes
Other Study ID Numbers: CEN/06/03/021
Study First Received: May 15, 2006
Last Updated: June 15, 2006
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Wellington Hospital:
Pterygium excision
Cut and paste
Tisseel fibrin glue
Conjunctival autograft

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014