Comparison of Glue With Sutures for Pterygium Surgery

Pterygium Clinical Trial

Official title:

Comparison of Cut and Paste With Sutured Autograft Pterygium Excision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00326560
• Other study ID #: CEN/06/03/021
• Status: Recruiting
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: June 15, 2006
• Start date: May 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2006
• Source: Wellington Hospital
• Contact: Reece C Hall, MBChB
• Phone: 0064 4 3855999
• Email: reece.hall[@]ccdhb.org.nz
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Primary pterygium

Exclusion Criteria:

• Ocular surface disease

• Previous pterygium surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• Pterygium excision and conjunctival autograft

Locations

Country	Name	City	State
New Zealand	Wellington Ophthalmology Department, Capital Coast District Health Board	Wellington

Sponsors (2)

Lead Sponsor	Collaborator
Wellington Hospital	Baxter Healthcare Corporation

Country where clinical trial is conducted

New Zealand, 

References & Publications (3)

Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. — View Citation

Koranyi G, Seregard S, Kopp ED. The cut-and-paste method for primary pterygium surgery: long-term follow-up. Acta Ophthalmol Scand. 2005 Jun;83(3):298-301. — View Citation

Uy HS, Reyes JM, Flores JD, Lim-Bon-Siong R. Comparison of fibrin glue and sutures for attaching conjunctival autografts after pterygium excision. Ophthalmology. 2005 Apr;112(4):667-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery time
Primary	Patient discomfort at day one, week one, two, four
Primary	Recurrence rate at months three, six, twelve