Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Not Applicable

Terminated

• Conditions: Pseudoexfoliation Syndrome; Phacoemulsification; Mydriasis; Cataract
• Interventions: Procedure: Intracameral injection of mydriatic agent

• Registration Number: NCT00690222
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICM	Intracameral injection of mydriatic agent	Intracameral mydriasis without pseudoexfoliation
ICM - PXF	Intracameral injection of mydriatic agent	Intracameral Mydriasis with pseudoexfoliation

Primary Outcome Measures

Name	Time	Method
Pupil size	At beginning and completion of cataract surgery

Secondary Outcome Measures

Name	Time	Method
Heart rate	Peri-operatively
Blood pressure	Peri-operatively

Trial Locations

Locations (1)

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada