We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070602
First Posted: February 18, 2010
Last Update Posted: July 1, 2013
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.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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 Intervention
Intraoperative Floppy Iris Syndrome Procedure: anterior (more central) corneal paracentesis incision

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Meir Medical Center:

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

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

Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anterior corneal incision Procedure: anterior (more central) corneal paracentesis incision
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01070602


Locations
Israel
Meir Medical Center Recruiting
Kfar-Saba, Israel
Contact: Fani Segev, Md.    972-52-6995044      
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01070602     History of Changes
Other Study ID Numbers: SRIFIS-001
First Submitted: February 17, 2010
First Posted: February 18, 2010
Last Update Posted: July 1, 2013
Last Verified: March 2013

Keywords provided by Meir Medical Center:
IFIS

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes