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)
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00627913
First received: February 25, 2008
Last updated: April 22, 2010
Last verified: January 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 22, 2014