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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01070602
First received: February 17, 2010
Last updated: June 27, 2013
Last verified: March 2013
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • assessing the clinical grade of observed IFIS cases [ Time Frame: during the operations ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01070602     History of Changes
Other Study ID Numbers: SRIFIS-001
Study First Received: February 17, 2010
Last Updated: June 27, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
IFIS

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014