Flomax Study for Floppy Iris Syndrome

Male patients scheduled for cataract surgery who are currently taking tamsulosin will be
recruited into the study. Age-matched male control patients undergoing cataract surgery,
without a history of using any a-adrenergic antagonist medication, will also be recruited.
Careful diagnostic iris evaluation using iris Fluorescein Angiography (FA) and Anterior
Segment Optical Coherence Tomography (AS-OCT) will be performed prior to cataract surgery.
Intraoperative findings and surgical complications will be recorded in an effort to
correlate preoperative diagnostic iris FA and AS-OCT findings with presence and severity of
intraoperative floppy iris syndrome (IFIS). The investigators hypothesize that males on
tamsulosin will have abnormal iris blood vessels on iris FA and altered iris morphology,
consistent with iris atrophy, on AS-OCT that will correlate with presence of IFIS and help
elucidate the pathophysiology of tamsulosin-induced IFIS.

Male patients scheduled for cataract surgery who are currently taking tamsulosin will be
eligible for enrollment into the study if they have no other conditions that affect the iris
vasculature and architecture (i.e. diabetes mellitus, glaucoma, pseudoexfoliation syndrome,
history of prior eye surgery or eye trauma, use of eye drops other than artificial tears and
normal preoperative drops). Control patients will be eligible if they have no history of use
of any a-adrenergic antagonist (tamsulosin, alfuzosin, doxazosin, or terazosin). Patients
who are interested in participating will be given a copy of the study consent form to take
home with them. These patients will then be contacted by the study coordinator for further
discussion of the study details. Study volunteers will be asked to come to the Kellogg Eye
Center any time prior to their scheduled surgery. Volunteers will undergo the informed
consent process, sign the consent form and be given a study identification number, linked to
the patient in a de-identified fashion, that will be used exclusively for the study. The
link of the study identification number and patient will be kept in a locked cabinet in the
clinic coordinator's locked office. All patient study information will be collected and
encoded according to HIPAA guidelines and institutional review board approval. The
investigators plan to enroll 20 patients and 10 age-matched controls in a 12-month
enrollment period.

- Iris Fluorescein Angiography (FA) will be performed in the surgical eye. The volunteer
will be seated at the Heidelberg Spectralis (Heidelberg Engineering, Heidelberg,
Germany) system. Sodium fluorescein dye (2mL of 25% solution) will be injected
intravenously, and video images of the iris vasculature will be recorded as the
fluorescent dye circulates through the iris blood vessels. The images will be digitally
recorded and assigned the volunteer's study identification number. Data collected from
this procedure includes circumferential extent of vascular filling (number of clock
hours), radial extent of vascular filling (percent of iris radius), delay in iris
circulation (time from dye injection to maximal filling of iris vasculature), blood
vessel tortuosity and alterations in caliber. This procedure takes approximately 20
minutes.

- Anterior Segment Optical Coherence Tomography (AS-OCT) will be performed in the
surgical eye. The volunteer will be seated at the Visante OCT (Carl Zeiss Meditec,
Dublin, CA) in a room with standardized lighting. They will be instructed to look at a
visual target within the instrument, and three high-resolution images of the anterior
segment of the eye will be acquired and saved, identified only with the volunteer's
study identification number. Data collected from this procedure includes iris leaflet
thickness and pupil diameter in a controlled lighting situation. This procedure takes
approximately 10 minutes.

Surgery will be performed according to the individual surgeon's preferences, including the
use of any iris manipulation techniques that are clinically necessary. Surgical parameters
will be recorded on a study visit form with the volunteer's study identification number:

- Pupil diameter will be measured with calipers at the beginning of surgery prior to
incision, and at the end, after intraocular lens implantation, but prior to
instillation of any miotic agents. These time points are before and after any
intra-operative iris expansion techniques could be performed. The surgeon will also
record whether he/she uses any iris expansion technique (i.e. iris hooks, Malyugin
ring, non-standard pupil dilation medications), which one, and at what point in the
procedure the technique was employed.

- Iris billowing will be graded as present or absent.

- Iris prolapse will be graded as present or absent.

- Surgical time from incision to dressing will be recorded.

- Surgical complications or any other surgical findings of interest to the surgeon will
be recorded.

Inclusion Criteria:

- Male

- 18 years or older

- Scheduled for Cataract Surgery

- Current or Past use of Tamsulosin (flomax)

- Blue colored iris

For controls, no history of Flomax

Exclusion Criteria:

- Females

- Diabetes

- Glaucoma

- Use of medicated eye drops

- Trauma or prior surgery to the eye

- Black or brown iris