Intraoperative Floppy Iris Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Floppy Iris Syndrome
• Intervention / Treatment: Device: DisCoVisc; Device: Healon5

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Study Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day Postoperative
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	1 Day Postoperative
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.	1 Day Postoperative
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	1 Day Postoperative
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	Time of Surgery

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (Estimate): July 8, 2008

Study Record Updates

• Last Update Posted (Estimate): August 10, 2010
• Last Update Submitted That Met QC Criteria: August 4, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Discovisc; Ophthalmic Visco Surgical Device
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lens Diseases; Syndrome; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: M07-013