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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

This study has been terminated.
(Funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690222
First Posted: June 4, 2008
Last Update Posted: March 25, 2015
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.
Information provided by (Responsible Party):
Nova Scotia Health Authority
May 30, 2008
June 4, 2008
March 25, 2015
March 2008
June 2012   (Final data collection date for primary outcome measure)
Pupil size [ Time Frame: At beginning and completion of cataract surgery ]
Same as current
Complete list of historical versions of study NCT00690222 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: Peri-operatively ]
  • Heart rate [ Time Frame: Peri-operatively ]
Same as current
Not Provided
Not Provided
 
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cataract
  • Phacoemulsification
  • Mydriasis
  • Pseudoexfoliation Syndrome
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
    Topical mydriasis without pseudoexfoliation
  • Experimental: ICM
    Intracameral mydriasis without pseudoexfoliation
    Intervention: Procedure: Intracameral injection of mydriatic agent
  • No Intervention: TM - PXF
    Topical mydriasis with pseudoexfoliation
  • Experimental: ICM - PXF
    Intracameral Mydriasis with pseudoexfoliation
    Intervention: Procedure: Intracameral injection of mydriatic agent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
June 2012
June 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00690222
CHDA-RS/2008-024
No
Not Provided
Not Provided
Nova Scotia Health Authority
Nova Scotia Health Authority
Not Provided
Not Provided
Nova Scotia Health Authority
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP