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Intraoperative Floppy Iris Syndrome

Primary Purpose

Cataract, Floppy Iris Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
DisCoVisc
Healon5
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Discovisc, Ophthalmic Visco Surgical Device

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with floppy iris syndrome
  • operable bilateral cataracts

Exclusion Criteria:

  • Intraocular Pressure (IOP) > 21mmHg
  • ocular inflammatory disease
  • systemic or ocular diseases affecting Endothelial Cell Count

Sites / Locations

  • Contact Alcon Call Center for Study Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DisCoVisc

Healon5

Arm Description

Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Outcomes

Primary Outcome Measures

Corneal Endothelial Cell Loss
Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.

Secondary Outcome Measures

Intraocular Pressure (IOP)
Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.
Aqueous Signs - Cells
Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells
Aqueous Signs - Flare
Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye. Mild-Flare visible against dark papillary background but not visible against iris background. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.
Aqueous Signs - Edema
Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none = mild - slight localized or generalized edema = moderate - significant localized or generalized edema = severe - advanced localized or generalized edema
Surgeon Survey
Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective

Full Information

First Posted
July 3, 2008
Last Updated
August 4, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00711347
Brief Title
Intraoperative Floppy Iris Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Floppy Iris Syndrome
Keywords
Discovisc, Ophthalmic Visco Surgical Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DisCoVisc
Arm Type
Active Comparator
Arm Description
Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Arm Title
Healon5
Arm Type
Active Comparator
Arm Description
Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Intervention Type
Device
Intervention Name(s)
DisCoVisc
Intervention Description
Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.
Intervention Type
Device
Intervention Name(s)
Healon5
Intervention Description
Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.
Primary Outcome Measure Information:
Title
Corneal Endothelial Cell Loss
Description
Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.
Time Frame
1 Day Postoperative
Title
Aqueous Signs - Cells
Description
Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells
Time Frame
1 Day Postoperative
Title
Aqueous Signs - Flare
Description
Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye. Mild-Flare visible against dark papillary background but not visible against iris background. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.
Time Frame
1 Day Postoperative
Title
Aqueous Signs - Edema
Description
Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none = mild - slight localized or generalized edema = moderate - significant localized or generalized edema = severe - advanced localized or generalized edema
Time Frame
1 Day Postoperative
Title
Surgeon Survey
Description
Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective
Time Frame
Time of Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with floppy iris syndrome operable bilateral cataracts Exclusion Criteria: Intraocular Pressure (IOP) > 21mmHg ocular inflammatory disease systemic or ocular diseases affecting Endothelial Cell Count
Facility Information:
Facility Name
Contact Alcon Call Center for Study Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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Intraoperative Floppy Iris Syndrome

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