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Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome

This study has been terminated.
(Study terminated due to insufficient subject participation)
Information provided by:
Penn State University Identifier:
First received: February 25, 2008
Last updated: April 22, 2010
Last verified: January 2008
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Pupil diameter after hydrodissection [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Pupil diameter after nuclear removal [ Time Frame: 2 years ]
  • Pupil diameter after cortex removal [ Time Frame: 2 years ]
  • Pupil diameter at conclusion of surgery [ Time Frame: 2 years ]

Enrollment: 6
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
Active Comparator: 1
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.
Experimental: 2
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00627913

United States, Pennsylvania
Penn State Hershey Eye Center
Hershey, Pennsylvania, United States, 17036
Sponsors and Collaborators
Penn State University
Principal Investigator: Ahmad A Aref, M.D. The Penn State Hershey Eye Center
  More Information

Responsible Party: Ahmad A. Aref, M.D., Penn State Hershey Eye Center Identifier: NCT00627913     History of Changes
Other Study ID Numbers: 27170
Study First Received: February 25, 2008
Last Updated: April 22, 2010

Keywords provided by Penn State University:
Floppy Iris Syndrome

Additional relevant MeSH terms:
Pathologic Processes
Hyaluronic Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Protective Agents processed this record on August 17, 2017