Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

This study has been terminated.
Information provided by (Responsible Party):
Nova Scotia Health Authority Identifier:
First received: May 30, 2008
Last updated: March 24, 2015
Last verified: May 2008

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
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:

Further study details as provided by Nova Scotia Health Authority:

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 ]

Enrollment: 80
Study Start Date: March 2008
Study Completion Date: June 2012
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00690222

Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Nova Scotia Health Authority
  More Information

Responsible Party: Nova Scotia Health Authority Identifier: NCT00690222     History of Changes
Other Study ID Numbers: CHDA-RS/2008-024 
Study First Received: May 30, 2008
Last Updated: March 24, 2015
Health Authority: Capital Health: Canada

Keywords provided by Nova Scotia Health Authority:
cataract surgery
pseudoexfoliation syndrome

Additional relevant MeSH terms:
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Lens Diseases
Pupil Disorders
Uveal Diseases
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on May 24, 2016