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Comparison of Glue With Sutures for Pterygium Surgery

Primary Purpose

Pterygium

Status
Unknown status
Phase
Phase 3
Locations
New Zealand
Study Type
Interventional
Intervention
Pterygium excision and conjunctival autograft
Sponsored by
Wellington Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium excision, Cut and paste, Tisseel fibrin glue, Conjunctival autograft

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Primary pterygium Exclusion Criteria: Ocular surface disease Previous pterygium surgery

Sites / Locations

  • Wellington Ophthalmology Department, Capital Coast District Health BoardRecruiting

Outcomes

Primary Outcome Measures

Surgery time
Patient discomfort at day one, week one, two, four
Recurrence rate at months three, six, twelve

Secondary Outcome Measures

Full Information

First Posted
May 15, 2006
Last Updated
June 15, 2006
Sponsor
Wellington Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00326560
Brief Title
Comparison of Glue With Sutures for Pterygium Surgery
Official Title
Comparison of Cut and Paste With Sutured Autograft Pterygium Excision
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wellington Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Pterygium excision, Cut and paste, Tisseel fibrin glue, Conjunctival autograft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Pterygium excision and conjunctival autograft
Primary Outcome Measure Information:
Title
Surgery time
Title
Patient discomfort at day one, week one, two, four
Title
Recurrence rate at months three, six, twelve

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary pterygium Exclusion Criteria: Ocular surface disease Previous pterygium surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reece C Hall, MBChB
Phone
0064 4 3855999
Ext
pager2566
Email
reece.hall@ccdhb.org.nz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reece C Hall, MBChB
Organizational Affiliation
Capital Coast District Health Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellington Ophthalmology Department, Capital Coast District Health Board
City
Wellington
ZIP/Postal Code
6001
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reece C Hall, MBChB
Phone
0064 4 3855999
Ext
page2566
Email
reece.hall@ccdhb.org.nz
First Name & Middle Initial & Last Name & Degree
Reece C Hall, MBChB

12. IPD Sharing Statement

Citations:
PubMed Identifier
15948780
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. doi: 10.1111/j.1600-0420.2005.00465.x.
Results Reference
background
PubMed Identifier
15808260
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. doi: 10.1016/j.ophtha.2004.08.028.
Results Reference
background
PubMed Identifier
15205236
Citation
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. doi: 10.1136/bjo.2003.032854.
Results Reference
background
PubMed Identifier
19702708
Citation
Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.
Results Reference
derived

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Comparison of Glue With Sutures for Pterygium Surgery

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