A Novel Technique for the Removal of Pterygiums

NCT ID: NCT02321150

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Pterygium

Keywords

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Pterygium Pterygiums Pterygia Graft Autograft Excision Surgery Eye electrocautery polyglactin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sutures

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

Group Type ACTIVE_COMPARATOR

Sutures

Intervention Type PROCEDURE

* 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

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.

Group Type EXPERIMENTAL

Cautery

Intervention Type PROCEDURE

* 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.

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Mentor O&O Wetfield Coagulator Polyglactin, Vicryl

Eligibility Criteria

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Inclusion Criteria

* Patients with one or more pterygiums over age 18

Exclusion Criteria

* Patients with glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of The West Indies

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kim Jebodhsingh

Consultant Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim N Jebodhsingh, MBBS, DABO

Role: PRINCIPAL_INVESTIGATOR

The Queen Elizabeth Hospital

Locations

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Queen Elizabeth Hospital

Bridgetown, , Barbados

Site Status

Countries

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Barbados

Other Identifiers

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KJebodhsingh

Identifier Type: -

Identifier Source: org_study_id