MedDataX Logo

Comparison of Glue With Sutures for Pterygium Surgery

NCT ID: NCT00326560

Last Updated: 2006-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pterygium

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pterygium excision Cut and paste Tisseel fibrin glue Conjunctival autograft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pterygium excision and conjunctival autograft

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary pterygium

Exclusion Criteria

* Ocular surface disease
* Previous pterygium surgery
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Wellington Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reece C Hall, MBChB

Role: PRINCIPAL_INVESTIGATOR

Capital Coast District Health Board

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wellington Ophthalmology Department, Capital Coast District Health Board

Wellington, , New Zealand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

New Zealand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reece C Hall, MBChB

Role: CONTACT

Phone: 0064 4 3855999

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Reece C Hall, MBChB

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15948780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15808260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15205236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19702708 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEN/06/03/021

Identifier Type: -

Identifier Source: org_study_id