Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Terminated

CT.gov ID

NCT00690222

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Phacoemulsification Mydriasis Pseudoexfoliation Syndrome	Procedure: Intracameral injection of mydriatic agent	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: TM Topical mydriasis without pseudoexfoliation
Experimental: ICM Intracameral mydriasis without pseudoexfoliation	Procedure: Intracameral injection of mydriatic agent 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	Procedure: Intracameral injection of mydriatic agent A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery

Outcome Measures

Primary Outcome Measures

Pupil size [At beginning and completion of cataract surgery]

Secondary Outcome Measures

Blood pressure [Peri-operatively]
Heart rate [Peri-operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)