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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070602
Recruitment Status : Unknown
Verified March 2013 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2010
Last Update Posted : July 1, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intraoperative Floppy Iris Syndrome Procedure: anterior (more central) corneal paracentesis incision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: anterior corneal incision Procedure: anterior (more central) corneal paracentesis incision
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.

Primary Outcome Measures :
  1. the number of IFIS cases observed during operation. [ Time Frame: during the operations ]

Secondary Outcome Measures :
  1. assessing the clinical grade of observed IFIS cases [ Time Frame: during the operations ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070602

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Meir Medical Center Recruiting
Kfar-Saba, Israel
Contact: Fani Segev, Md.    972-52-6995044      
Sponsors and Collaborators
Meir Medical Center
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Responsible Party: Meir Medical Center Identifier: NCT01070602    
Other Study ID Numbers: SRIFIS-001
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: March 2013
Keywords provided by Meir Medical Center:
Additional relevant MeSH terms:
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Pathologic Processes