The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients

Intraoperative Floppy Iris Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01070602
• Other study ID #: SRIFIS-001
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2010
• Last updated: June 27, 2013
• Start date: July 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate.

Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. cataract candidates treated (in the present or in the past) with tamsulosin

2. aged 55 or more

3. candidates for topical anesthesia

4. no allergy to anticholinergic or adrenergic drugs

5. able to understand and sign an informed consent

Exclusion Criteria:

1. history of uveitis

2. iris neovascularization

3. s/p iris surgery

4. traumatic/uveitis induced cataract

5. dialysis / abscence of zonules

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraoperative Floppy Iris Syndrome

Intervention

Procedure:
• anterior (more central) corneal paracentesis incision
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of IFIS cases observed during operation.		during the operations	Yes
Secondary	assessing the clinical grade of observed IFIS cases		during the operations	Yes