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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
Information provided by (Responsible Party):
Capital District Health Authority, Canada Identifier:
First received: May 30, 2008
Last updated: February 8, 2012
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 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


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00690222

Contact: Andrew W Kirker, MD 902 473 3226

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 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
pseudoexfoliation syndrome

Additional relevant MeSH terms:
Exfoliation Syndrome
Eye Diseases
Iris Diseases
Lens Diseases
Pathologic Processes
Pupil Disorders
Uveal Diseases processed this record on February 27, 2015