Official Title: “Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2010

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Healon 5
• Experimental: 2
  • Retrobulbar Anesthetic Injection

Primary Measures

• Preoperative pupil diameter, pupil diameter after hydrodissection, pupil diameter after nuclear removal, pupil diameter after cortex removal, and pupil diameter at conclusion of surgery.
  • Time Frame: 2 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Penn State University

Overall Clinical Trial Officials and Contacts

Ahmad A Aref, M.D. Principal Investigator The Penn State Hershey Eye Center  

Overall Contact: Ahmad A Aref, M.D. (717) 531-8783 aaref@hmc.psu.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627913

Study ID Number: 27170

ClinicalTrials.gov Identifier: NCT00627913

Health Authority: United States: Institutional Review Board