An interventional study of Cauterization and Fibrin glue in Pterygium of Conjunctiva and Cornea, sponsored by University of Split, School of Medicine. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment
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.
Exclusion criteria:
Procedure: Cauterization
Procedure: Fibrin glue
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.
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.
Recurrence of pterygium
Any re-growth of tissue from the area of excision across the limbus onto the cornea.
Time frame: 180 days
Surgical time
Surgical time: total operational time required for completion of the operation (measured in minutes)
Time frame: During the surgery
Complication rate
Complication rate will be analyzed as the occurrence of at least one of the following major complications such as dehiscence, displacement or loss of the autograft, infection, haemorrhage, oedema, fibrosis, retraction and other indications that required special treatment
Time frame: 7, 30 and 180 days
Pterygium-induced astigmatism
Measured as described by Hsu 2014
Time frame: 7, 30 and 180 days
Ocular surface condition
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.
Time frame: 7, 30 and 180 days
Postoperative discomfort, tearing, pain and foreign body sensation
Using modified scale from Lim Bon Siong et al: (0) none, no pain, (1) very mild, (2) mild, pain causing some discomfort, (3) moderate, pain that partially interferes with usual activity or sleep, (4) sever, pain that completely interferes with usual activity or sleep.
Time frame: 7, 30 and 180 days
Pain
Numerical rating scale (NRS) ranging from 0 to 10, where 0 = No pain and 10 = Pain as intense as you can imagine.
Time frame: 7, 30 and 180 days
Economic Analysis
Cost of each intervention
Time frame: 180 days
Flap time
Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes)
Time frame: During the surgery
Plan to share: Yes — Anonymized individual participant data will be made available to other researchers on request.
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University of Split, School of Medicine