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| Sponsored by: |
Penn State University |
|---|---|
| Information provided by: | Penn State University |
| ClinicalTrials.gov Identifier: | NCT00627913 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Intraoperative Floppy Iris Syndrome |
Procedure: Healon 5 injection Procedure: Retrobulbar anesthetic injection |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Healon 5
|
Procedure: Healon 5 injection
Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement.
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2: Experimental
Retrobulbar Anesthetic Injection
|
Procedure: Retrobulbar anesthetic injection
3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ahmad A Aref, M.D. | (717) 531-8783 | aaref@hmc.psu.edu |
| Contact: Ali Aminlari, M.D., FACS | (717) 531-8783 | aaminlari@hmc.psu.edu |
| United States, Pennsylvania | |
| Penn State Hershey Eye Center | Recruiting |
| Hershey, Pennsylvania, United States, 17036 | |
| Contact: Ahmad A Aref, M.D. 717-531-8783 aaref@hmc.psu.edu | |
| Principal Investigator: Ahmad A Aref, M.D. | |
| Sub-Investigator: Ali Aminlari, M.D., FACS | |
| Sub-Investigator: Ingrid U. Scott, M.D. | |
| Principal Investigator: | Ahmad A Aref, M.D. | The Penn State Hershey Eye Center |
More Information
| Responsible Party: | Penn State Hershey Eye Center ( Ahmad A. Aref, M.D. ) |
| Study ID Numbers: | 27170 |
| Study First Received: | February 25, 2008 |
| Last Updated: | September 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00627913 |
| Health Authority: | United States: Institutional Review Board |
|
Floppy Iris Syndrome |
|
Hyaluronic Acid Lidocaine Bupivacaine |
|
Pathologic Processes Disease Immunologic Factors Syndrome |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |
