PterygiumNCT02321150
A Novel Technique for the Removal of Pterygiums
A study testing Cautery and Sutures in people with Pterygium, run by The University of The West Indies at 1 site in Barbados.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Cautery and Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBarbados
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one or more pterygiums over age 18
Who cannot join
- Patients with glaucoma
Trial locations and contacts
1 site in 1 country.
Barbados1 site
Queen Elizabeth Hospital
Bridgetown
About this study
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
- Being tested
- Cautery, Sutures
- Keywords
- Pterygium, Pterygiums, Pterygia, Graft, Autograft, Excision, Surgery, Eye, electrocautery, polyglactin
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CauteryProcedure or surgery
Also called 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.
SuturesProcedure or surgery
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Sutures | Active comparator | After pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures. Receives: 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. Receives: Procedure: Cautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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;
- = 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.
Measured: 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;
- = 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.
Measured: 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;
- = 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.
Measured: 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;
- = 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.
Measured: 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;
- = 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.
Measured: 3 months
Secondary outcomes (1)
Operating time
Analysis. start time of operation, start time of conjunctival graft attachment and end time of operation will be recorded.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kim Jebodhsingh, The University of The West Indies
- Investigators
- Kim N Jebodhsingh, MBBS, DABO, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321150
- Sponsor's protocol ID
- KJebodhsingh
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique for the Removal of Pterygiums
- ClinicalTrials.gov ID
- NCT02321150
- Acronym / sponsor ID
- KJebodhsingh
- Conditions
- Pterygium
- Keywords
- Pterygium, Pterygiums, Pterygia, Graft, Autograft, Excision, Surgery, Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sutures | Active comparator | Procedure: SuturesAfter pterygium removal the conjunctival graft to cover bare sclera will be secured with interrupted 8.0 polyglactin sutures. |
| Cautery | Experimental | Procedure: CauteryAfter pterygium removal the conjunctival graft to cover bare sclera will be secured with bipolar electrocautery, power set at 25 until whitening of tissue observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with one or more pterygiums over age 18
Key exclusion criteria (1 listed)
- Patients with glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CauteryAlso: 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. | Procedure or surgery | Cautery |
| SuturesAlso: 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 | Procedure or surgery | Sutures |
Primary outcome
Patient Discomfort
Time frame: Day 1
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.
Patient Discomfort
Time frame: Week 1
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.
Patient Discomfort
Time frame: Week 2
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.
Patient Discomfort
Time frame: Week 3
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.
Patient Discomfort
Time frame: Week 7
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.
Patient Discomfort
Time frame: 3 months
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.
1 secondary outcome
Operating time
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim N Jebodhsingh, MBBS, DABO principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cautery and Sutures in people with Pterygium, run by The University of The West Indies at 1 site in Barbados.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Barbados. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Discomfort (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.