Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome - Full Text View

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Cataract

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Pupil diameter after hydrodissection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pupil diameter after nuclear removal [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Pupil diameter after cortex removal [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Pupil diameter at conclusion of surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627913

Locations

United States, Pennsylvania
Penn State Hershey Eye Center
Hershey, Pennsylvania, United States, 17036

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator:

Ahmad A Aref, M.D.

The Penn State Hershey Eye Center

More Information

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.

Responsible Party:	Ahmad A. Aref, M.D., Penn State Hershey Eye Center
ClinicalTrials.gov Identifier:	NCT00627913 History of Changes
Other Study ID Numbers:	27170
Study First Received:	February 25, 2008
Last Updated:	April 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Floppy Iris Syndrome

Additional relevant MeSH terms:

Anesthetics
Hyaluronic Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012