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

Not Applicable

• Conditions: Intraoperative Floppy Iris Syndrome
• Interventions: Procedure: anterior (more central) corneal paracentesis incision

• Registration Number: NCT01070602
• Lead Sponsor: Meir Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-07-01
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

1. history of uveitis
2. iris neovascularization
3. s/p iris surgery
4. traumatic/uveitis induced cataract
5. dialysis / abscence of zonules

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anterior corneal incision	anterior (more central) corneal paracentesis incision	-

Primary Outcome Measures

Name	Time	Method
the number of IFIS cases observed during operation.	during the operations

Secondary Outcome Measures

Name	Time	Method
assessing the clinical grade of observed IFIS cases	during the operations

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel