Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome
Information source: Penn State University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraoperative Floppy Iris Syndrome
Intervention: Healon 5 injection (Procedure); Retrobulbar anesthetic injection (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Ahmad A Aref, M.D., Principal Investigator, Affiliation: The Penn State Hershey Eye Center
Overall contact:
Ahmad A Aref, M.D., Phone: (717) 531-8783, Email: aaref@hmc.psu.edu
Summary
In this study, the investigators plan to compare the incidence and complications of
intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking
tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection
of Healon 5 viscoelastic into the anterior chamber.
Clinical Details
Official title: Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome
Study design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Preoperative pupil diameter, pupil diameter after hydrodissection, pupil diameter after nuclear removal, pupil diameter after cortex removal, and pupil diameter at conclusion of surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All cataract patients taking tamsulosin
Exclusion Criteria:
- Patients with any history of iridocyclitis
- Presence of iris neovascularization
- History of prior iris surgery
- Presence of traumatic cataracts
- Presence of zonular dialysis
Locations and Contacts
Ahmad A Aref, M.D., Phone: (717) 531-8783, Email: aaref@hmc.psu.edu
Penn State Hershey Eye Center, Hershey, Pennsylvania 17036, United States; Recruiting
Ahmad A Aref, M.D., Phone: 717-531-8783, Email: aaref@hmc.psu.edu
Ahmad A Aref, M.D., Principal Investigator
Ali Aminlari, M.D., FACS, Sub-Investigator
Ingrid U. Scott, M.D., Sub-Investigator
Additional Information
Related publications: Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64.
Starting date: February 2008
Ending date: May 2010
Last updated: September 5, 2008
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