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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01070602
Enrollment
40
Registered
2010-02-18
Start date
2010-07-31
Completion date
2014-03-31
Last updated
2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Floppy Iris Syndrome

Keywords

IFIS

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.

Interventions

PROCEDUREanterior (more central) corneal paracentesis incision

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

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the number of IFIS cases observed during operation.during the operations

Secondary

MeasureTime frame
assessing the clinical grade of observed IFIS casesduring the operations

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026