Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT00326560
Status:
UNKNOWN
Last Update Posted:
2006-06-16
First Post:
2006-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glue With Sutures for Pterygium Surgery
Sponsor:
Wellington Hospital
Organization:
Study Overview
Official Title:
Comparison of Cut and Paste With Sutured Autograft Pterygium Excision
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: