A Novel Technique for the Removal of Pterygiums

Pterygium Clinical Trial

Official title:

A Novel Technique for the Removal of Pterygiums

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02321150
• Other study ID #: KJebodhsingh
• Status: Unknown status
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 26, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with one or more pterygiums over age 18

Exclusion Criteria:

• Patients with glaucoma

Related Conditions & MeSH terms

• Pterygium

Intervention

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.
• 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

Locations

Country	Name	City	State
Barbados	Queen Elizabeth Hospital	Bridgetown

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Barbados, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Recurrence	Any regrowth of the pterygium onto the cornea will be considered a recurrence	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Operating time	Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded.	day 1