Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract Phacoemulsification Mydriasis Pseudoexfoliation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TM

Topical mydriasis without pseudoexfoliation

Group Type NO_INTERVENTION

No interventions assigned to this group

ICM

Intracameral mydriasis without pseudoexfoliation

Group Type EXPERIMENTAL

Intracameral injection of mydriatic agent

Intervention Type PROCEDURE

A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery

TM - PXF

Topical mydriasis with pseudoexfoliation

Group Type NO_INTERVENTION

No interventions assigned to this group

ICM - PXF

Intracameral Mydriasis with pseudoexfoliation

Group Type EXPERIMENTAL

Intracameral injection of mydriatic agent

Intervention Type PROCEDURE

A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No