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TerminatedNCT00690222Updated Mar 25, 2015

Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

An interventional study of Intracameral injection of mydriatic agent in Cataract, Phacoemulsification and Mydriasis, sponsored by Nova Scotia Health Authority. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
  • Phacoemulsification
  • Mydriasis
  • Pseudoexfoliation Syndrome

Keywords

  • cataract surgery
  • phacoemulsification
  • pupil
  • dilation
  • mydriasis
  • intracameral
  • topical
  • pseudoexfoliation syndrome
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 80 is close to the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    TM

    Topical mydriasis without pseudoexfoliation

  • Experimental
    ICM

    Intracameral mydriasis without pseudoexfoliation

    Procedure: Intracameral injection of mydriatic agent

  • No intervention
    TM - PXF

    Topical mydriasis with pseudoexfoliation

  • Experimental
    ICM - PXF

    Intracameral Mydriasis with pseudoexfoliation

    Procedure: Intracameral injection of mydriatic agent

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

06

What researchers measure

Primary outcomes

  1. Pupil size

    Time frame: At beginning and completion of cataract surgery

Secondary outcomes

  1. Blood pressure

    Time frame: Peri-operatively

  2. Heart rate

    Time frame: Peri-operatively

07

Study locations

1 site
  • Capital District Health Authority
    Halifax, Nova Scotia B3H 2Y9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00690222
Responsible party
Sponsor
First posted
Jun 4, 2008
Start date
Mar 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Mar 25, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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