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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

Primary Purpose

Cataract, Phacoemulsification, Mydriasis

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intracameral injection of mydriatic agent
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract surgery, phacoemulsification, pupil, dilation, mydriasis, intracameral, topical, pseudoexfoliation syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Capital District Health Authority

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

TM

ICM

TM - PXF

ICM - PXF

Arm Description

Topical mydriasis without pseudoexfoliation

Intracameral mydriasis without pseudoexfoliation

Topical mydriasis with pseudoexfoliation

Intracameral Mydriasis with pseudoexfoliation

Outcomes

Primary Outcome Measures

Pupil size

Secondary Outcome Measures

Blood pressure
Heart rate

Full Information

First Posted
May 30, 2008
Last Updated
March 24, 2015
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT00690222
Brief Title
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Funding
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Phacoemulsification, Mydriasis, Pseudoexfoliation Syndrome
Keywords
cataract surgery, phacoemulsification, pupil, dilation, mydriasis, intracameral, topical, pseudoexfoliation syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TM
Arm Type
No Intervention
Arm Description
Topical mydriasis without pseudoexfoliation
Arm Title
ICM
Arm Type
Experimental
Arm Description
Intracameral mydriasis without pseudoexfoliation
Arm Title
TM - PXF
Arm Type
No Intervention
Arm Description
Topical mydriasis with pseudoexfoliation
Arm Title
ICM - PXF
Arm Type
Experimental
Arm Description
Intracameral Mydriasis with pseudoexfoliation
Intervention Type
Procedure
Intervention Name(s)
Intracameral injection of mydriatic agent
Intervention Description
A mixture of 0.2 % tropicamide and 2% phenylephrine will be injected into the anterior chamber at the beginning of surgery
Primary Outcome Measure Information:
Title
Pupil size
Time Frame
At beginning and completion of cataract surgery
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
Peri-operatively
Title
Heart rate
Time Frame
Peri-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada

12. IPD Sharing Statement

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Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

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