- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00326560
Comparison of Glue With Sutures for Pterygium Surgery
June 15, 2006 updated by: Wellington Hospital
Comparison of Cut and Paste With Sutured Autograft Pterygium Excision
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reece C Hall, MBChB
- Phone Number: pager2566 0064 4 3855999
- Email: reece.hall@ccdhb.org.nz
Study Locations
-
-
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Wellington, New Zealand, 6001
- Recruiting
- Wellington Ophthalmology Department, Capital Coast District Health Board
-
Contact:
- Reece C Hall, MBChB
- Phone Number: page2566 0064 4 3855999
- Email: reece.hall@ccdhb.org.nz
-
Principal Investigator:
- Reece C Hall, MBChB
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary pterygium
Exclusion Criteria:
- Ocular surface disease
- Previous pterygium surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Surgery time
|
Patient discomfort at day one, week one, two, four
|
Recurrence rate at months three, six, twelve
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Reece C Hall, MBChB, Capital Coast District Health Board
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion
September 1, 2007
Study Registration Dates
First Submitted
May 15, 2006
First Submitted That Met QC Criteria
May 15, 2006
First Posted (Estimate)
May 17, 2006
Study Record Updates
Last Update Posted (Estimate)
June 16, 2006
Last Update Submitted That Met QC Criteria
June 15, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEN/06/03/021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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