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

Intraoperative Floppy Iris Syndrome Clinical Trial

Official title:

Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00627913
• Other study ID #: 27170
• Status: Terminated
• Phase: N/A
• First received: February 25, 2008
• Last updated: November 21, 2017
• Start date: February 2008
• Est. completion date: November 11, 2010

Study information

• Verified date: November 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 11, 2010
• Est. primary completion date: November 11, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Floppy Iris Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Hershey Eye Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameter after hydrodissection		2 years
Secondary	Pupil diameter after nuclear removal		2 years
Secondary	Pupil diameter after cortex removal		2 years
Secondary	Pupil diameter at conclusion of surgery		2 years