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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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00690222
Enrollment
80
Registered
2008-06-04
Start date
2008-03-31
Completion date
2012-06-30
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Mydriasis, Phacoemulsification, Pseudoexfoliation Syndrome

Keywords

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

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.

Interventions

PROCEDUREIntracameral 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

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Pupil sizeAt beginning and completion of cataract surgery

Secondary

MeasureTime frame
Blood pressurePeri-operatively
Heart ratePeri-operatively

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026