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

Not Applicable

Terminated

• Conditions: Intraoperative Floppy Iris Syndrome
• Interventions: Procedure: Healon 5 injection; Procedure: Retrobulbar anesthetic injection

• Registration Number: NCT00627913
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-04
• Primary Completion: 2010-11-11
• Study Completion: 2010-11-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Healon 5 injection	Healon 5
2	Retrobulbar anesthetic injection	Retrobulbar Anesthetic Injection

Primary Outcome Measures

Name	Time	Method
Pupil diameter after hydrodissection	2 years

Secondary Outcome Measures

Name	Time	Method
Pupil diameter at conclusion of surgery	2 years
Pupil diameter after nuclear removal	2 years
Pupil diameter after cortex removal	2 years

Trial Locations

Locations (1)

Penn State Hershey Eye Center; 🇺🇸 Hershey, Pennsylvania, United States