PterygiumNCT01249235
Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
A study testing Patch or bandage contact lens 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 patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Patch or bandage contact lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Oct 2011
- 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
- Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
- Ability to understand the nature of the procedure and to complete all measurement requirements
- Adults (age greater than 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
- 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)
- Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
- Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)
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 Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.
- Conditions
- Pterygium
- Being tested
- Patch or bandage contact lens
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch or bandage contact lensProcedure or surgery
Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patch | Active comparator | The operative eye will be patched. Receives: Procedure: Patch or bandage contact lens |
| Bandage Contact Lens | Experimental | The operative eye will have a bandage contact lens Receives: Procedure: Patch or bandage contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score
Measured: 1 week
Secondary outcomes (3)
Sensitivity to light, tearing, foreign body sensation
Measured: 1 week
Postoperative Complications
Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation
Measured: 1 week
Number of Tylenol #3 tablets required
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2011 (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
- 60 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
- NCT01249235
- Sponsor's protocol ID
- REB-10-0538
- Status last verified
- Oct 2010
- First submitted
- 22 Nov 2010
- Last updated
- 29 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
- ClinicalTrials.gov ID
- NCT01249235
- Acronym / sponsor ID
- REB-10-0538
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 29 Nov 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 patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch | Active comparator | Procedure: Patch or bandage contact lensThe operative eye will be patched. |
| Bandage Contact Lens | Experimental | Procedure: Patch or bandage contact lensThe operative eye will have a bandage contact lens |
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
- Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
- Ability to understand the nature of the procedure and to complete all measurement requirements
- Adults (age greater than 18)
Key exclusion criteria (6 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
- 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)
- Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
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 |
|---|---|---|
| Patch or bandage contact lensPatients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery. | Procedure or surgery | Bandage Contact Lens, Patch |
Primary outcome
Visual Analog Pain Score
Time frame: 1 week
3 secondary outcomes
Sensitivity to light, tearing, foreign body sensation
Time frame: 1 week
Postoperative Complications
Time frame: 1 week
Number of Tylenol #3 tablets required
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2010.
Related trials for Pterygium
Not yet recruiting
Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery
Pterygium, Preoperative Anxiety
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruitingPhase 1
Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application
Diabetic Foot Ulcer (DFU), Ocular Disorder
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
Recruiting
Conjunctival Transpositional Surgery for Primary Pterygium
Pterygium of the Conjunctiva and Cornea
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 Patch or bandage contact lens 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 6 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 29 Nov 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?
Visual Analog Pain Score (time frame: 1 week). 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 29 Nov 2010.