Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cauterization, Fibrin glue.
- Who it may be relevant to
- Registry conditions: Pterygium of Conjunctiva and Cornea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Pterygium is a noncancerous growth of the conjunctival tissue over the cornea. It is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. In this randomized controlled cauterization will be compared with fibrin glue for conjunctival autografting in primary pterygium surgery.
Interventions
- Procedure 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 addition - Procedure 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.
Primary outcome measures
- Recurrence of pterygium [Time frame: 180 days]
Secondary outcome measures (8)
- Surgical time [Time frame: During the surgery]
- Complication rate [Time frame: 7, 30 and 180 days]
- Pterygium-induced astigmatism [Time frame: 7, 30 and 180 days]
- Ocular surface condition [Time frame: 7, 30 and 180 days]
- Postoperative discomfort, tearing, pain and foreign body sensation [Time frame: 7, 30 and 180 days]
- Pain [Time frame: 7, 30 and 180 days]
- Economic Analysis [Time frame: 180 days]
- Flap time [Time frame: During the surgery]
Eligibility criteria
Inclusion criteria
- adults (older than 18 years of age)
- 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
- connective tissue disease
- prior eye surgery
- chronic use of topical drugs (anti-glaucoma drugs)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- University Hospital Split — Split
Publications
- 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. PMID 29950464
Identifiers
NCT: NCT03321201 · PTERYGIUM1