- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00690222
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 2Y9
- Capital District Health Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: TM
Topical mydriasis without pseudoexfoliation
|
|
Experimental: ICM
Intracameral mydriasis without pseudoexfoliation
|
A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery
|
No Intervention: TM - PXF
Topical mydriasis with pseudoexfoliation
|
|
Experimental: ICM - PXF
Intracameral Mydriasis with pseudoexfoliation
|
A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pupil size
Time Frame: At beginning and completion of cataract surgery
|
At beginning and completion of cataract surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: Peri-operatively
|
Peri-operatively
|
Heart rate
Time Frame: Peri-operatively
|
Peri-operatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHDA-RS/2008-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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