PterygiumNCT01261455
Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
A study testing Location of the autograft taken following pterygium excision in people with Pterygium, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Location of the autograft taken following pterygium excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Oct 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
- Ability to understand the nature of the procedure and to complete all measurement requirements
- Patients must be eligible for either the superior or inferior conjunctival autografts (they must not meet any of the following exclusion criteria)
- Adults (age >18)
Who cannot join
- Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
- Patients who have had previous ocular surface surgery
- Patients with glaucoma or those who may need glaucoma surgery in the future
- Contraindications to local anesthetics (such as known allergy)
- Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
Trial locations and contacts
1 site in 1 country.
Allan Slomovic, MD contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital, University of Toronto
Toronto, Ontario, M5T 2S8
Sonia Yeung, MD, sonia.yeung@utoronto.ca
About this study
Official title: Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
The purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. The investigators will also be recording the level of pain felt by patients after surgery, any difficulties during or after surgery, and if the pterygium grows back.
- Conditions
- Pterygium
- Being tested
- Location of the autograft taken following pterygium excision
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location of the autograft taken following pterygium excisionProcedure or surgery
Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.
| Study group | Role | What they receive |
|---|---|---|
| Superior Conjunctival Autograft | Active comparator | Conjunctival autograft following pterygium excision is taken from superior conjunctival tissue. Receives: Procedure: Location of the autograft taken following pterygium excision |
| Inferior Conjunctival Autograft | Experimental | Conjunctival autograft following pterygium excision is taken from inferior conjunctival tissue. Receives: Procedure: Location of the autograft taken following pterygium excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to complete the surgical procedure (minutes)
Measured: 1 year
Secondary outcomes (3)
Visual Analog Pain Score
Measured: 1 week
Recurrence of pterygium
Measured: 1 year
Intraoperative and Postoperative Complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Allan Slomovic, MD, Principal investigator, Toronto Western Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261455
- Sponsor's protocol ID
- REB-09-0999A
- Status last verified
- Oct 2010
- First submitted
- 22 Nov 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
- ClinicalTrials.gov ID
- NCT01261455
- Acronym / sponsor ID
- REB-09-0999A
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 16 Dec 2010 (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 purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. The investigators will also be recording the level of pain felt by patients after surgery, any difficulties during or after surgery, and if the pterygium grows back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior Conjunctival Autograft | Active comparator | Procedure: Location of the autograft taken following pterygium excisionConjunctival autograft following pterygium excision is taken from superior conjunctival tissue. |
| Inferior Conjunctival Autograft | Experimental | Procedure: Location of the autograft taken following pterygium excisionConjunctival autograft following pterygium excision is taken from inferior conjunctival tissue. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
- Ability to understand the nature of the procedure and to complete all measurement requirements
- Patients must be eligible for either the superior or inferior conjunctival autografts (they must not meet any of the following exclusion criteria)
- Adults (age >18)
Key exclusion criteria (5 listed)
- Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
- Patients who have had previous ocular surface surgery
- Patients with glaucoma or those who may need glaucoma surgery in the future
- Contraindications to local anesthetics (such as known allergy)
- Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
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 |
|---|---|---|
| Location of the autograft taken following pterygium excisionFollowing pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva. | Procedure or surgery | Inferior Conjunctival Autograft, Superior Conjunctival Autograft |
Primary outcome
Time taken to complete the surgical procedure (minutes)
Time frame: 1 year
3 secondary outcomes
Visual Analog Pain Score
Time frame: 1 week
Recurrence of pterygium
Time frame: 1 year
Intraoperative and Postoperative Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
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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.
Allan Slomovic, MD contact
Allan Slomovic, MD principal investigator
Toronto Western Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Location of the autograft taken following pterygium excision in people with Pterygium, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 5 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 16 Dec 2010. 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 Canada. 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?
Contact Allan Slomovic, MD (allan.slomovic@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to complete the surgical procedure (minutes) (time frame: 1 year). 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 16 Dec 2010.