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

NCT ID: NCT01070602

Last Updated: 2013-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intraoperative Floppy Iris Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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anterior corneal incision

Group Type EXPERIMENTAL

anterior (more central) corneal paracentesis incision

Intervention Type PROCEDURE

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

Interventions

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anterior (more central) corneal paracentesis incision

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Fani Segev, Md.

Role: primary

972-52-6995044

Other Identifiers

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SRIFIS-001

Identifier Type: -

Identifier Source: org_study_id

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