Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
Stopped: Pupil measurement methodology determined not appropriate in this population.
Austria, Germany18 participantsStarted 2014-02
Plain-language summary
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Competent to provide informed consent.
✓. Voluntarily provide informed consent and HIPAA Authorization in accordance with local regulations and governing IEC/IRB requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
✓. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions.
✓. Are male and 18 years of age or older at the time of surgery.
✓. Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an intraocular lens.
✓. Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
✓. Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the study eye.
✓. Is currently and has been taking tamsulosin (Flomax®) for at least six months.
Exclusion criteria
✕. Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including aspirin.
✕. Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as hydroxypropylmethylcellulose or hyaluronic acid or latex..
✕. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory or other medical condition that could increase the risk to the subject as determined by the Investigator.
✕. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia).
✕. Presence of systolic blood pressure of greater than 170 mmHg or less than 90 mmHg, or diastolic blood pressure of greater than110 mmHg or less than 40 mmHg at the screening visit.
✕. Use of phenylephrine in the study eye (other than for the screening ophthalmological examination) within seven days prior to the day of surgery.
✕. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.
✕. Use of pilocarpine in the study eye within seven days prior to the day of surgery.