A Novel Technique for the Removal of Pterygiums

Study Overview
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Brief Summary
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The aim of this study is to introduce a new surgical technique for the removal of pterygiums that entails the use of bipolar electrocautery to secure the graft, rather than sutures. With this, the objective is to evaluate the benefits of a new technique for pterygium surgery with respect to postoperative patient comfort, surgery time, cost and recurrence rate.

Official Title
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A Novel Technique for the Removal of Pterygiums

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Cautery
* Procedure: Sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with one or more pterygiums over age 18 Exclusion Criteria: Patients with glaucoma

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sutures<br>After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures. | Procedure: Sutures<br>* Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique. Conjunctiva undermined at the recipient site. Graft is slid into place The graft is secured to host conjunctiva using 7 interrupted sutures<br>* Other names: Polyglactin, Vicryl;|
| Experimental: Cautery<br>After pterygium removal the conjunctival graft to cover bare sclera will be secured with bipolar electrocautery, power set at 25 until whitening of tissue observed. | Procedure: Cautery<br>* Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique. Conjunctiva undermined at the recipient site. Relaxing incisions placed at the corners of the recipient site. Graft is slid into place Graft / host interface is gently dried with a Qtip Bipolar cautery is applied after grasping the graft and host conjunctiva gently between cautery forceps. Power setting: 25. Duration of cautery: 4 -5 seconds; the tissue should whiten and contract as desiccation and coagulation take place. Some charring may occur. Counter traction is applied to the conjunctiva as the cautery forceps are gently teased off Cautery is applied at the 4 apices of the graft then in between these points.<br>* Other names: Mentor O&O Wetfield Coagulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | Day 1 | 
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | Week 1 | 
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | Week 2 | 
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | Week 3 | 
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | Week 7 | 
| Patient Discomfort | Grading of patients' symptoms (pain, foreign body sensation, irritation, and epiphora) will be done using a 5-point scale. The scale ranges from 0 to 4: 0 = no symptom at all; = presence of the symptom but easily tolerated; = presence of the symptom causing some discomfort; = presence of the symptom causing discomfort that interferes with usual activity or sleep; = presence of the symptom that completely interferes with usual activity or sleep. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye, Pterygium, Pterygiums, Pterygia, Graft, Autograft, Excision, Surgery, electrocautery, polyglactin