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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00326560
Registration number
NCT00326560
Ethics application status
Date submitted
15/05/2006
Date registered
17/05/2006
Date last updated
16/06/2006
Titles & IDs
Public title
Comparison of Glue With Sutures for Pterygium Surgery
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Scientific title
Comparison of Cut and Paste With Sutured Autograft Pterygium Excision
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Secondary ID [1]
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CEN/06/03/021
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pterygium
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Pterygium excision and conjunctival autograft
Treatment: Surgery: Pterygium excision and conjunctival autograft
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Surgery time
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Patient discomfort at day one, week one, two, four
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Recurrence rate at months three, six, twelve
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Assessment method [3]
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Timepoint [3]
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Eligibility
Key inclusion criteria
- Primary pterygium
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Ocular surface disease
- Previous pterygium surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Wellington Hospital
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Baxter Healthcare Corporation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00326560
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Trial related presentations / publications
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.
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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Reece C Hall, MBChB
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Address
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Capital Coast District Health Board
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reece C Hall, MBChB
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Address
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Country
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Phone
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0064 4 3855999
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00326560
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