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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690222
Recruitment Status : Terminated (Funding)
First Posted : June 4, 2008
Last Update Posted : March 25, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cataract Phacoemulsification Mydriasis Pseudoexfoliation Syndrome Procedure: Intracameral injection of mydriatic agent Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Tropicamide

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

Primary Outcome Measures :
  1. Pupil size [ Time Frame: At beginning and completion of cataract surgery ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Peri-operatively ]
  2. Heart rate [ Time Frame: Peri-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00690222

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

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Responsible Party: Nova Scotia Health Authority Identifier: NCT00690222     History of Changes
Other Study ID Numbers: CHDA-RS/2008-024
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: May 2008
Keywords provided by Nova Scotia Health Authority:
cataract surgery
pseudoexfoliation syndrome
Additional relevant MeSH terms:
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Exfoliation Syndrome
Pathologic Processes
Lens Diseases
Eye Diseases
Iris Diseases
Uveal Diseases
Pupil Disorders
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Muscarinic Antagonists