Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
NCT ID: NCT03321201
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
164 participants
INTERVENTIONAL
2018-05-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cauterization
Cauterization
To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed.
Fibrin glue
Fibrin glue
Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse.
Interventions
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Cauterization
To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed.
Fibrin glue
Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse.
Eligibility Criteria
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Inclusion Criteria
* both sexes
* primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons
* if the patients had a bilateral pterygium, only one eye will be operated
Exclusion Criteria
* prior eye surgery
* chronic use of topical drugs (anti-glaucoma drugs)
18 Years
ALL
No
Sponsors
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University Hospital of Split
OTHER
University of Split, School of Medicine
OTHER
Responsible Party
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Livia Puljak
Associate Professor
Locations
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University Hospital Split
Split, , Croatia
Countries
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Facility Contacts
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Role: backup
References
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Lesin M, Paradzik M, Marin Lovric J, Olujic I, Ljubic Z, Vucinovic A, Bucan K, Puljak L. Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial. BMJ Open. 2018 Jun 27;8(6):e020714. doi: 10.1136/bmjopen-2017-020714.
Other Identifiers
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PTERYGIUM1
Identifier Type: -
Identifier Source: org_study_id
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