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

Primary Purpose

Intraoperative Floppy Iris Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
anterior (more central) corneal paracentesis incision
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Floppy Iris Syndrome focused on measuring IFIS

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anterior corneal incision

Arm Description

Outcomes

Primary Outcome Measures

the number of IFIS cases observed during operation.

Secondary Outcome Measures

assessing the clinical grade of observed IFIS cases

Full Information

First Posted
February 17, 2010
Last Updated
June 27, 2013
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01070602
Brief Title
The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Floppy Iris Syndrome
Keywords
IFIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anterior corneal incision
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
anterior (more central) corneal paracentesis incision
Intervention Description
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.
Primary Outcome Measure Information:
Title
the number of IFIS cases observed during operation.
Time Frame
during the operations
Secondary Outcome Measure Information:
Title
assessing the clinical grade of observed IFIS cases
Time Frame
during the operations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cataract candidates treated (in the present or in the past) with tamsulosin aged 55 or more candidates for topical anesthesia no allergy to anticholinergic or adrenergic drugs able to understand and sign an informed consent Exclusion Criteria: history of uveitis iris neovascularization s/p iris surgery traumatic/uveitis induced cataract dialysis / abscence of zonules
Facility Information:
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fani Segev, Md.
Phone
972-52-6995044

12. IPD Sharing Statement

Learn more about this trial

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

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