The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
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|ClinicalTrials.gov Identifier: NCT01070602|
Recruitment Status : Unknown
Verified March 2013 by Meir Medical Center.
Recruitment status was: Recruiting
First Posted : February 18, 2010
Last Update Posted : July 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Intraoperative Floppy Iris Syndrome||Procedure: anterior (more central) corneal paracentesis incision||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||March 2014|
|Experimental: anterior corneal incision||
Procedure: anterior (more central) corneal paracentesis incision
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.
- the number of IFIS cases observed during operation. [ Time Frame: during the operations ]
- assessing the clinical grade of observed IFIS cases [ Time Frame: during the operations ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070602
|Meir Medical Center||Recruiting|
|Contact: Fani Segev, Md. 972-52-6995044|