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

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01070602
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 44
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Floppy Iris Syndrome	Procedure: anterior (more central) corneal paracentesis incision	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anterior corneal incision	Procedure: anterior (more central) corneal paracentesis incision; 3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.

Outcome Measures

Primary Outcome Measures

1. the number of IFIS cases observed during operation. [during the operations]

Secondary Outcome Measures

1. assessing the clinical grade of observed IFIS cases [during the operations]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar-Saba		Israel

Sponsors and Collaborators

• Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01070602
• Other Study ID Numbers: SRIFIS-001
• First Posted: Feb 18, 2010
• Last Update Posted: Jul 1, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Meir Medical Center: IFIS
• Additional relevant MeSH terms: Syndrome

Study Results

No Results Posted as of Jul 1, 2013