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

• Sponsor: Penn State University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00627913
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 33.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2008
• Actual Primary Completion Date: Nov 11, 2010
• Actual Study Completion Date: Nov 11, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pupil diameter after hydrodissection [2 years]

Secondary Outcome Measures

1. Pupil diameter after nuclear removal [2 years]

2. Pupil diameter after cortex removal [2 years]

3. Pupil diameter at conclusion of surgery [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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: Penn State University
• ClinicalTrials.gov Identifier: NCT00627913
• Other Study ID Numbers: 27170
• First Posted: Mar 4, 2008
• Last Update Posted: Nov 24, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Penn State University: Floppy Iris Syndrome
• Additional relevant MeSH terms: Syndrome; Anesthetics

Study Results

No Results Posted as of Nov 24, 2017