Intraoperative Floppy Iris Syndrome
- Conditions
- CataractFloppy Iris Syndrome
- Interventions
- Device: DisCoViscDevice: Healon5
- Registration Number
- NCT00711347
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- diagnosed with floppy iris syndrome
- operable bilateral cataracts
- Intraocular Pressure (IOP) > 21mmHg
- ocular inflammatory disease
- systemic or ocular diseases affecting Endothelial Cell Count
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DisCoVisc DisCoVisc Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery Healon5 Healon5 Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
- Primary Outcome Measures
Name Time Method Corneal Endothelial Cell Loss 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
Name Time Method Intraocular Pressure (IOP) 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.
Aqueous Signs - Cells 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
Aqueous Signs - Flare 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.Aqueous Signs - Edema 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 edemaSurgeon Survey 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
Trial Locations
- Locations (1)
Contact Alcon Call Center for Study Locations
🇺🇸Fort Worth, Texas, United States