A Novel Technique for the Removal of Pterygiums

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.

Study Overview

• Status: Unknown
• Conditions: Pterygium
• Intervention / Treatment: Procedure: Sutures; Procedure: Cautery

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Barbados
  • Bridgetown, Barbados
    • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with one or more pterygiums over age 18

Exclusion Criteria:

• Patients with glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sutures; After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures.	Procedure: Sutures; 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; Other Names: Polyglactin, Vicryl
EXPERIMENTAL: Cautery; 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; 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.; Other Names: Mentor O&O Wetfield Coagulator

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating Cost	Cost Benefit Analysis. Total cost of pterygium surgery using sutures for graft attachment versus cost using cautery for graft attachment will be calculated and compared.	day 1
Recurrence	Any regrowth of the pterygium onto the cornea will be considered a recurrence	1 year

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Kim N Jebodhsingh, MBBS, DABO, The Queen Elizabeth Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (ESTIMATE): December 22, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 26, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Surgery; Pterygium; Eye; Autograft; Excision; Graft; electrocautery; polyglactin; Pterygiums; Pterygia
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium
• Other Study ID Numbers: KJebodhsingh