Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Nova Scotia Health Authority (NSHA)

Status: Terminated

Conditions: Pseudoexfoliation Syndrome; Cataract; Phacoemulsification; Mydriasis

Treatments: Procedure: Intracameral injection of mydriatic agent

Study type: Interventional

Funder types: Other

Identifiers

NCT00690222

CHDA-RS/2008-024

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 4 patient groups

TM

No Intervention group

Description:

Topical mydriasis without pseudoexfoliation

ICM

Experimental group

Description:

Intracameral mydriasis without pseudoexfoliation

Treatment:

Procedure: Intracameral injection of mydriatic agent

TM - PXF

No Intervention group

Description:

Topical mydriasis with pseudoexfoliation

ICM - PXF

Experimental group

Description:

Intracameral Mydriasis with pseudoexfoliation

Treatment:

Procedure: Intracameral injection of mydriatic agent