A Novel Technique for the Removal of Pterygiums

NCT02321150 | Unknown DMC

• 1 other identifier: KJebodhsingh
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Keywords

Pterygium; Pterygiums; Pterygia; Graft; Autograft; Excision; Surgery; Eye; electrocautery; polyglactin

Outcome Measures

Primary Outcomes (6)

• 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = 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; 1. = presence of the symptom but easily tolerated; 2. = presence of the symptom causing some discomfort; 3. = presence of the symptom causing discomfort that interferes with usual activity or sleep; 4. = presence of the symptom that completely interferes with usual activity or sleep.

  3 months

Secondary Outcomes (1)

• Operating time

  day 1

Other Outcomes (2)

• Operating Cost

  day 1

• Recurrence

  1 year

Study Arms (2)

Sutures

ACTIVE COMPARATOR

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

Procedure: Sutures

Cautery

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.

Procedure: Cautery

Interventions

Cautery 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.

Also known as: Mentor O&O Wetfield Coagulator

Cautery

Sutures 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

Also known as: Polyglactin, Vicryl

Sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with one or more pterygiums over age 18

You may not qualify if:

• Patients with glaucoma

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

Queen Elizabeth Hospital

Bridgetown, Barbados

Location

MeSH Terms

Conditions

Pterygium

Interventions

Cautery; Sutures; Polyglactin 910

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kim N Jebodhsingh, MBBS, DABO

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 22, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

BA (1)