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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

This study has been terminated.
(Funding)
Sponsor:
Information provided by (Responsible Party):
Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT00690222
First received: May 30, 2008
Last updated: March 24, 2015
Last verified: May 2008
  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
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 ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Peri-operatively ]
  • Heart rate [ Time Frame: Peri-operatively ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT00690222

Locations
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
ClinicalTrials.gov Identifier: NCT00690222     History of Changes
Other Study ID Numbers: CHDA-RS/2008-024
Study First Received: May 30, 2008
Last Updated: March 24, 2015

Keywords provided by Nova Scotia Health Authority:
cataract surgery
phacoemulsification
pupil
dilation
mydriasis
intracameral
topical
pseudoexfoliation syndrome

Additional relevant MeSH terms:
Syndrome
Cataract
Mydriasis
Exfoliation Syndrome
Disease
Pathologic Processes
Lens Diseases
Eye Diseases
Pupil Disorders
Iris Diseases
Uveal Diseases
Mydriatics
Tropicamide
Phenylephrine
Oxymetazoline
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on May 24, 2017