Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

NCT00690222 | Terminated

• 1 other identifier: CHDA-RS/2008-024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Phacoemulsification; Mydriasis; Pseudoexfoliation Syndrome

Keywords

cataract surgery; phacoemulsification; pupil; dilation; mydriasis; intracameral; topical; pseudoexfoliation syndrome

Outcome Measures

Primary Outcomes (1)

• Pupil size

  At beginning and completion of cataract surgery

Secondary Outcomes (2)

• Blood pressure

  Peri-operatively

• Heart rate

  Peri-operatively

Study Arms (4)

TM

NO INTERVENTION

Topical mydriasis without pseudoexfoliation

ICM

EXPERIMENTAL

Intracameral mydriasis without pseudoexfoliation

Procedure: Intracameral injection of mydriatic agent

TM - PXF

NO INTERVENTION

Topical mydriasis with pseudoexfoliation

ICM - PXF

EXPERIMENTAL

Intracameral Mydriasis with pseudoexfoliation

Procedure: Intracameral injection of mydriatic agent

Interventions

Intracameral injection of mydriatic agent PROCEDURE

A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery

ICM; ICM - PXF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Cataract; Mydriasis; Exfoliation Syndrome; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pupil Disorders; Iris Diseases; Uveal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 4, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 25, 2015

Record last verified: 2008-05

Locations

CA (1)