CataractNCT00690222
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery
A study testing Intracameral injection of mydriatic agent in people with Cataract and Phacoemulsification, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Phacoemulsification, Mydriasis
- What is being tested?
- Intracameral injection of mydriatic agent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give consent
- Greater than 18 years of age
- Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens
- No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.)
- Systemic condition capable of undergoing topical anesthesia
- No previous intraocular surgery
- Pseudoexfoliation syndrome (PXF) for group 1
- No Pseudoexfoliation syndrome for group 2
Who cannot join
- Not fulfilling inclusion criteria
- Any iris pathology including but not limited to posterior synechia, iridocorneal endothelial syndrome, corectopia, traumatic mydriasis, Horner's syndrome, Adie's pupil, cyclodialysis, iridodialysis
- Previous or concurrent use of Flomax® or similar alpha-antagonist medication
- Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning, sclerocornea, scarring)
- Uncontrolled Hypertension (greater than 170/90 on pre-operative assessment on day of surgery as measured by automated DATEX monitor)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Intracameral Phenylephrine 2% and Tropicamide 0.2% With Topical Phenylephrine 2.5% and Tropicamide 1% for Pupillary Dilation During Cataract Surgery on Patients With and Without Pseudoexfoliation Syndrome.
The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients, those with and those without pseudoexfoliation syndrome.
We will be looking at how each method affects the size of the pupil at the beginning and at the end of cataract surgery. In addittion, we will look at what effect the two different methods have on blood pressure and heart rate in the pre-operative, peri-operative and post-operative periods.
- Conditions
- Cataract, Phacoemulsification, Mydriasis, Pseudoexfoliation Syndrome
- Being tested
- Intracameral injection of mydriatic agent
- Keywords
- cataract surgery, phacoemulsification, pupil, dilation, mydriasis, intracameral, topical, pseudoexfoliation syndrome
- Medical subject headings
- Cataract, Mydriasis, Exfoliation Syndrome, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracameral injection of mydriatic agentProcedure or surgery
A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery
| Study group | Role | What they receive |
|---|---|---|
| TM | No intervention | Topical mydriasis without pseudoexfoliation |
| ICM | Experimental | Intracameral mydriasis without pseudoexfoliation Receives: Procedure: Intracameral injection of mydriatic agent |
| TM - PXF | No intervention | Topical mydriasis with pseudoexfoliation |
| ICM - PXF | Experimental | Intracameral Mydriasis with pseudoexfoliation Receives: Procedure: Intracameral injection of mydriatic agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil size
Measured: At beginning and completion of cataract surgery
Secondary outcomes (2)
Blood pressure
Measured: Peri-operatively
Heart rate
Measured: Peri-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690222
- Sponsor's protocol ID
- CHDA-RS/2008-024
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intracameral Phenylephrine 2% and Tropicamide 0.2% With Topical Phenylephrine 2.5% and Tropicamide 1% for Pupillary Dilation During Cataract Surgery on Patients With and Without Pseudoexfoliation Syndrome.
- ClinicalTrials.gov ID
- NCT00690222
- Acronym / sponsor ID
- CHDA-RS/2008-024
- Conditions
- Cataract, Phacoemulsification, Mydriasis, Pseudoexfoliation Syndrome
- Keywords
- cataract surgery, phacoemulsification, pupil, dilation, mydriasis, intracameral, topical, pseudoexfoliation syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Jun 2008 (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 is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients, those with and those without pseudoexfoliation syndrome.
We will be looking at how each method affects the size of the pupil at the beginning and at the end of cataract surgery. In addittion, we will look at what effect the two different methods have on blood pressure and heart rate in the pre-operative, peri-operative and post-operative periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TM | No intervention | –Topical mydriasis without pseudoexfoliation |
| ICM | Experimental | Procedure: Intracameral injection of mydriatic agentIntracameral mydriasis without pseudoexfoliation |
| TM - PXF | No intervention | –Topical mydriasis with pseudoexfoliation |
| ICM - PXF | Experimental | Procedure: Intracameral injection of mydriatic agentIntracameral Mydriasis with pseudoexfoliation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to give consent
- Greater than 18 years of age
- Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens
- No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.)
- Systemic condition capable of undergoing topical anesthesia
Key exclusion criteria (5 listed)
- Not fulfilling inclusion criteria
- Any iris pathology including but not limited to posterior synechia, iridocorneal endothelial syndrome, corectopia, traumatic mydriasis, Horner's syndrome, Adie's pupil, cyclodialysis, iridodialysis
- Previous or concurrent use of Flomax® or similar alpha-antagonist medication
- Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning, sclerocornea, scarring)
- Uncontrolled Hypertension (greater than 170/90 on pre-operative assessment on day of surgery as measured by automated DATEX monitor)
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 |
|---|---|---|
| Intracameral injection of mydriatic agentA mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery | Procedure or surgery | ICM, ICM - PXF |
Primary outcome
Pupil size
Time frame: At beginning and completion of cataract surgery
2 secondary outcomes
Blood pressure
Time frame: Peri-operatively
Heart rate
Time frame: Peri-operatively
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracameral injection of mydriatic agent in people with Cataract and Phacoemulsification, run by Nova Scotia Health Authority 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 8 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: stopped early, as of the sponsor's last update on 25 Mar 2015. 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?
The study was stopped early (reason given: Funding). 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?
Pupil size (time frame: At beginning and completion of cataract surgery). 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 25 Mar 2015.