Overview

This trial is active, not recruiting.

Condition pterygium
Treatments cautery, sutures
Sponsor The University of The West Indies
Start date December 2013
End date December 2014
Trial size 50 participants
Trial identifier NCT02321150, KJebodhsingh

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures.
sutures Polyglactin, Vicryl
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
(Experimental)
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.
cautery Mentor O&O Wetfield Coagulator
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.

Primary Outcomes

Measure
Patient Discomfort
time frame: Day 1
Patient Discomfort
time frame: Week 1
Patient Discomfort
time frame: Week 2
Patient Discomfort
time frame: Week 3
Patient Discomfort
time frame: Week 7
Patient Discomfort
time frame: 3 months

Secondary Outcomes

Measure
Operating time
time frame: day 1

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Novel Technique for the Removal of Pterygiums
Principal investigator Kim N Jebodhsingh, MBBS, DABO
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by The University of The West Indies.