NCT01070602

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 1, 2013

Status Verified

March 1, 2013

Enrollment Period

3.4 years

First QC Date

February 17, 2010

Last Update Submit

June 27, 2013

Conditions

Intraoperative Floppy Iris Syndrome

Keywords

IFIS

Outcome Measures

Primary Outcomes (1)

  • the number of IFIS cases observed during operation.

    during the operations

Secondary Outcomes (1)

  • assessing the clinical grade of observed IFIS cases

    during the operations

Study Arms (1)

anterior corneal incision

EXPERIMENTAL
Procedure: anterior (more central) corneal paracentesis incision

Interventions

anterior (more central) corneal paracentesis incisionPROCEDURE

3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.

anterior corneal incision

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of uveitis
  • iris neovascularization
  • s/p iris surgery
  • traumatic/uveitis induced cataract
  • dialysis / abscence of zonules

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

July 1, 2013

Record last verified: 2013-03

Locations

IL(1)