Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Study Overview
=================
Brief 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. 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.

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.

Conditions
-----------------
Cataract, Phacoemulsification, Mydriasis, Pseudoexfoliation Syndrome

Intervention / Treatment
-----------------
* Procedure: Intracameral injection of mydriatic agent


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TM<br>Topical mydriasis without pseudoexfoliation | |
| Experimental: ICM<br>Intracameral mydriasis without pseudoexfoliation | Procedure: Intracameral injection of mydriatic agent<br>* A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery<br>|
| No Intervention: TM - PXF<br>Topical mydriasis with pseudoexfoliation | |
| Experimental: ICM - PXF<br>Intracameral Mydriasis with pseudoexfoliation | Procedure: Intracameral injection of mydriatic agent<br>* A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil size |  | At beginning and completion of cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Peri-operatively | 
| Heart rate |  | Peri-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, phacoemulsification, pupil, dilation, mydriasis, intracameral, topical, pseudoexfoliation syndrome