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

Clalit Health Services

Status: Unknown

Conditions: Intraoperative Floppy Iris Syndrome

Treatments: Procedure: anterior (more central) corneal paracentesis incision

Study type: Interventional

Funder types: Other

Identifiers

NCT01070602

SRIFIS-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

anterior corneal incision

Experimental group

Treatment:

Procedure: anterior (more central) corneal paracentesis incision