Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Cauterization Versus ﬁbrin Glue for Conjunctival Autografting in Primary Pterygium Surgery

Conditions
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Pterygium of Conjunctiva and Cornea

Intervention / Treatment
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* Procedure: Cauterization
* Procedure: Fibrin glue


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cauterization<br> | Procedure: Cauterization<br>* 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.<br>|
| Active Comparator: Fibrin glue<br> | Procedure: Fibrin glue<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pterygium | Any re-growth of tissue from the area of excision across the limbus onto the cornea. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | Surgical time: total operational time required for completion of the operation (measured in minutes) | 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 | 7, 30 and 180 days | 
| Pterygium-induced astigmatism | Measured as described by Hsu 2014 | 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. | 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. | 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. | 7, 30 and 180 days | 
| Economic Analysis | Cost of each intervention | 180 days | 
| Flap time | Time needed for preparing and repositioning of the conjunctival grafts (measured in minutes) | During the surgery |