Flomax Study for Floppy Iris Syndrome
Flomax Study for Floppy Iris Syndrome
Some men who have a history of use of Tamsulosin (Flomax) are at risk for a condition called
 Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract
 surgery. It is not fully understood why this condition develops or who is at risk for
 developing it. In this study the investigators will take pictures of the iris and iris blood
 vessels before cataract surgery. The investigators hope that the results of this study will
 provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give
 us a non-surgical way of figuring out who might develop this problem during surgery.
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