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Comparison of Glue With Sutures for Pterygium Surgery

Comparison of Cut and Paste With Sutured Autograft Pterygium Excision

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00326560
Enrollment
40
Registered
2006-05-17
Start date
2006-05-31
Completion date
2007-09-30
Last updated
2006-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium

Keywords

Pterygium excision, Cut and paste, Tisseel fibrin glue, Conjunctival autograft

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.

Interventions

PROCEDUREPterygium excision and conjunctival autograft

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Wellington Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Primary pterygium

Exclusion criteria

* Ocular surface disease * Previous pterygium surgery

Design outcomes

Primary

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

Countries

New Zealand

Contacts

Primary ContactReece C Hall, MBChB
reece.hall@ccdhb.org.nz0064 4 3855999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026