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

June 27, 2013 updated by: Meir Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
          • Fani Segev, Md.
          • Phone Number: 972-52-6995044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of IFIS cases observed during operation.
Time Frame: during the operations
during the operations

Secondary Outcome Measures

Outcome Measure
Time Frame
assessing the clinical grade of observed IFIS cases
Time Frame: during the operations
during the operations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (ESTIMATE)

February 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRIFIS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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