Comparison of Glue With Sutures for Pterygium Surgery
Comparison of Cut and Paste With Sutured Autograft Pterygium Excision
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2006
CompletedFirst Posted
Study publicly available on registry
May 17, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJune 16, 2006
May 1, 2006
May 15, 2006
June 15, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Surgery time
Patient discomfort at day one, week one, two, four
Recurrence rate at months three, six, twelve
Interventions
Eligibility Criteria
You may qualify if:
- Primary pterygium
You may not qualify if:
- Ocular surface disease
- Previous pterygium surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wellington Hospitallead
- Baxter Healthcare Corporationcollaborator
Study Sites (1)
Wellington Ophthalmology Department, Capital Coast District Health Board
Wellington, 6001, New Zealand
Related Publications (4)
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.
PMID: 15948780BACKGROUNDUy 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.
PMID: 15808260BACKGROUNDKoranyi 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.
PMID: 15205236BACKGROUNDHall 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.
PMID: 19702708DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reece C Hall, MBChB
Capital Coast District Health Board
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 15, 2006
First Posted
May 17, 2006
Study Start
May 1, 2006
Study Completion
September 1, 2007
Last Updated
June 16, 2006
Record last verified: 2006-05