Intraoperative Floppy Iris Syndrome

Study Overview
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Brief Summary
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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.

Conditions
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Cataract, Floppy Iris Syndrome

Intervention / Treatment
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* Device: DisCoVisc
* Device: Healon5


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discovisc, Ophthalmic Visco Surgical Device