Intraoperative Floppy Iris Syndrome

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.

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 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 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.

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

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