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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flomax | Male patients scheduled for cataract surgery with current or past use of Flomax | ||
| Control | Male adult patients scheduled for cataract surgery with no history of Flomax use |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Floppy Iris Syndrome | during cataract surgery |
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Inclusion Criteria:
For controls, no history of Flomax
Exclusion Criteria:
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Adult male patients seen and scheduled for cataract surgery at the Kellogg eye Centers in Ann Arbor, Livonia and Brighton campuses.
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| Name | Affiliation | Role |
|---|---|---|
| Roni Shtein, MD | University of Michigan Kellogg Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kellogg Eye Center, 1000 Wall Street | Ann Arbor | Michigan | 48105 | United States |
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