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A Novel Technique for the Removal of Pterygiums

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Barbados
Study Type
Interventional
Intervention
Cautery
Sutures
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Pterygiums, Pterygia, Graft, Autograft, Excision, Surgery, Eye, electrocautery, polyglactin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with one or more pterygiums over age 18

Exclusion Criteria:

  • Patients with glaucoma

Sites / Locations

  • Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sutures

Cautery

Arm Description

After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Operating time
Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded.

Full Information

First Posted
December 3, 2014
Last Updated
December 26, 2014
Sponsor
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT02321150
Brief Title
A Novel Technique for the Removal of Pterygiums
Official Title
A Novel Technique for the Removal of Pterygiums
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of The West Indies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Pterygium, Pterygiums, Pterygia, Graft, Autograft, Excision, Surgery, Eye, electrocautery, polyglactin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sutures
Arm Type
Active Comparator
Arm Description
After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures.
Arm Title
Cautery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cautery
Other Intervention Name(s)
Mentor O&O Wetfield Coagulator
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sutures
Other Intervention Name(s)
Polyglactin, Vicryl
Intervention Description
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
Primary Outcome Measure Information:
Title
Patient Discomfort
Description
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.
Time Frame
Day 1
Title
Patient Discomfort
Description
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.
Time Frame
Week 1
Title
Patient Discomfort
Description
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.
Time Frame
Week 2
Title
Patient Discomfort
Description
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.
Time Frame
Week 3
Title
Patient Discomfort
Description
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.
Time Frame
Week 7
Title
Patient Discomfort
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Operating time
Description
Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded.
Time Frame
day 1
Other Pre-specified Outcome Measures:
Title
Operating Cost
Description
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.
Time Frame
day 1
Title
Recurrence
Description
Any regrowth of the pterygium onto the cornea will be considered a recurrence
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with one or more pterygiums over age 18 Exclusion Criteria: Patients with glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim N Jebodhsingh, MBBS, DABO
Organizational Affiliation
The Queen Elizabeth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Bridgetown
Country
Barbados

12. IPD Sharing Statement

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A Novel Technique for the Removal of Pterygiums

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