Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00690222
• Other study ID #: CHDA-RS/2008-024
• Status: Terminated
• Phase: N/A
• First received: May 30, 2008
• Last updated: March 24, 2015
• Start date: March 2008
• Est. completion date: June 2012

Study information

• Verified date: May 2008
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Capital Health: Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Exfoliation Syndrome
• Mydriasis
• Phacoemulsification
• Pseudoexfoliation Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil size		At beginning and completion of cataract surgery	No
Secondary	Blood pressure		Peri-operatively	No
Secondary	Heart rate		Peri-operatively	No