Intraoperative Floppy Iris Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711347
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : August 4, 2010
Last Update Posted : August 10, 2010
Information provided by:
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Cataract Floppy Iris Syndrome Device: DisCoVisc Device: Healon5 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : June 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: DisCoVisc
Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Device: DisCoVisc
Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.
Active Comparator: Healon5
Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Device: Healon5
Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Primary Outcome Measures :
  1. Corneal Endothelial Cell Loss [ Time Frame: 1 month ]
    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 :
  1. Intraocular Pressure (IOP) [ Time Frame: 1 Day Postoperative ]
    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.

  2. Aqueous Signs - Cells [ Time Frame: 1 Day Postoperative ]
    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

  3. Aqueous Signs - Flare [ Time Frame: 1 Day Postoperative ]

    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.

    1. Mild-Flare visible against dark papillary background but not visible against iris background.
    2. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
    3. 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.

  4. Aqueous Signs - Edema [ Time Frame: 1 Day Postoperative ]

    Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:

    0 = none

    1. = mild - slight localized or generalized edema
    2. = moderate - significant localized or generalized edema
    3. = severe - advanced localized or generalized edema

  5. Surgeon Survey [ Time Frame: Time of Surgery ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711347

United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Rick Potvin, Alcon Laboratories, Inc. Identifier: NCT00711347     History of Changes
Other Study ID Numbers: M07-013
First Posted: July 8, 2008    Key Record Dates
Results First Posted: August 4, 2010
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by Alcon Research:
Ophthalmic Visco Surgical Device

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents