Cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery (CAGE CUP): study protocol of a randomised controlled trial.
Mladen Lešin, Martina Paradžik, Josipa Marin Lovrić...
https://pubmed.ncbi.nlm.nih.gov/29950464Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03321201
Cauterization Versus Fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Led by University of Split, School of Medicine · Updated on 2022-11-02
164
Participants Needed
1
Research Sites
87 weeks
Total Duration
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Sponsors
U
University of Split, School of Medicine
Lead Sponsor
U
University Hospital of Split
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pterygium is a noncancerous growth of the conjunctival tissue over the cornea that can progress to cause vision problems, eye movement restrictions, chronic inflammation, and cosmetic issues. This clinical trial evaluates and compares two methods for securing conjunctival autografts during primary pterygium surgery: cauterization and fibrin glue. The study is randomized and controlled to assess which method may influence recurrence rates and other outcomes. The two interventions studied are cauterization, where a bipolar cutter is used to secure the graft with controlled cauterizing wraps, and fibrin glue, where a fiber adhesive is prepared and applied to fix the graft. The fibrin glue preparation takes about 10 to 15 minutes and is performed by a nurse. Both procedures aim to secure the conjunctival autograft during surgery to prevent recurrence. Participants will be followed for 180 days after surgery to monitor the recurrence of pterygium, surgical time, complication rates, astigmatism caused by pterygium, ocular surface condition, and postoperative symptoms such as discomfort, tearing, pain, and foreign body sensation. Pain and economic analyses will also be assessed at various time points including 7, 30, and 180 days after surgery. The study includes triple masking and random allocation to study groups.
CONDITIONS
Brief Title
Cauterization Versus fibrin Glue for Conjunctival Autografting in Primary Pterygium Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years of age
- Both sexes
- Primary nasal pterygia measuring 4 mm or more that tends to increase, including patients with reduced visual acuity, chronic inflammation, or cosmetic reasons
- If bilateral pterygium is present, only one eye will be operated
You will not qualify if you...
- Connective tissue disease
- Prior eye surgery
- Chronic use of topical drugs such as anti-glaucoma medications
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - Day of surgery
Participants undergo primary pterygium surgery with conjunctival autografting using either cauterization or fibrin glue to secure the graft.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - 180 days
Participants are monitored for surgical outcomes, complications, pain, and ocular surface condition after surgery.
Visits at 7, 30, and 180 days post-surgery
Trial Site Locations
Total: 1 location
1
University Hospital Split
Split, Croatia, 21000
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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