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

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ClinicalTrials.gov Identifier: NCT00627913
Recruitment Status : Terminated (Study terminated due to insufficient subject participation)
First Posted : March 4, 2008
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Penn State University

Brief Summary:
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 or disease Intervention/treatment Phase
Intraoperative Floppy Iris Syndrome Procedure: Healon 5 injection Procedure: Retrobulbar anesthetic injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : November 11, 2010
Actual Study Completion Date : November 11, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00627913     History of Changes
Other Study ID Numbers: 27170
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Penn State University:
Floppy Iris Syndrome

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Anesthetics
Hyaluronic Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents