Intraoperative Floppy Iris Syndrome

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00711347
First received: July 3, 2008
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Cataract
Floppy Iris Syndrome
Device: DisCoVisc
Device: Healon5
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Endothelial Cell Loss [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 1 Day Postoperative ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 Day Postoperative ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 Day Postoperative ] [ Designated as safety issue: Yes ]

    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.

  • Aqueous Signs - Edema [ Time Frame: 1 Day Postoperative ] [ Designated as safety issue: Yes ]

    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

  • Surgeon Survey [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]

    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



Enrollment: 28
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711347

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

No publications provided

Responsible Party: Rick Potvin, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00711347     History of Changes
Other Study ID Numbers: M07-013
Study First Received: July 3, 2008
Results First Received: September 9, 2009
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Discovisc
Ophthalmic Visco Surgical Device

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2014