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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Capital District Health Authority, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00690222
First received: May 30, 2008
Last updated: February 8, 2012
Last verified: May 2008
History of Changes
  Purpose

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 Intervention
Cataract
Phacoemulsification
Mydriasis
Pseudoexfoliation Syndrome
 Procedure: Intracameral injection of mydriatic agent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Pupil size [ Time Frame: At beginning and completion of cataract surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Peri-operatively ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Peri-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690222

Contacts
Contact: Andrew W Kirker, MD 902 473 3226 kirker@eastlink.ca

Locations
Canada, Nova Scotia
Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Lisa H Heckler, MD     9024733226        
Sponsors and Collaborators
Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00690222     History of Changes
Other Study ID Numbers: CHDA-RS/2008-024
Study First Received: May 30, 2008
Last Updated: February 8, 2012
Health Authority: Capital Health: Canada

Keywords provided by Capital District Health Authority, Canada:
cataract surgery
phacoemulsification
pupil
dilation
 mydriasis
intracameral
topical
pseudoexfoliation syndrome

Additional relevant MeSH terms:
Mydriasis
Cataract
Exfoliation Syndrome
Pupil Disorders
Eye Diseases
Lens Diseases
Iris Diseases
Uveal Diseases
Mydriatics
Phenylephrine
Tropicamide
Oxymetazoline
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013