Intraoperative Floppy Iris SyndromeNCT01070602
The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
A study testing anterior (more central) corneal paracentesis incision in people with Intraoperative Floppy Iris Syndrome, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome
- What is being tested?
- anterior (more central) corneal paracentesis incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract candidates treated (in the present or in the past) with tamsulosin
- aged 55 or more
- candidates for topical anesthesia
- no allergy to anticholinergic or adrenergic drugs
- able to understand and sign an informed consent
Who cannot join
- history of uveitis
- iris neovascularization
- s/p iris surgery
- traumatic/uveitis induced cataract
- dialysis / abscence of zonules
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Fani Segev, Md., 972-52-6995044
About this study
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.
- Conditions
- Intraoperative Floppy Iris Syndrome
- Being tested
- anterior (more central) corneal paracentesis incision
- Keywords
- IFIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior (more central) corneal paracentesis incisionProcedure or surgery
3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.
| Study group | Role | What they receive |
|---|---|---|
| anterior corneal incision | Experimental | Not described Receives: Procedure: anterior (more central) corneal paracentesis incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of IFIS cases observed during operation.
Measured: during the operations
Secondary outcomes (1)
assessing the clinical grade of observed IFIS cases
Measured: during the operations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Floppy Iris SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070602
- Sponsor's protocol ID
- SRIFIS-001
- Status last verified
- Mar 2013
- First submitted
- 17 Feb 2010
- Last updated
- 1 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
- ClinicalTrials.gov ID
- NCT01070602
- Acronym / sponsor ID
- SRIFIS-001
- Conditions
- Intraoperative Floppy Iris Syndrome
- Keywords
- IFIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anterior corneal incision | Experimental | Procedure: anterior (more central) corneal paracentesis incision |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- cataract candidates treated (in the present or in the past) with tamsulosin
- aged 55 or more
- candidates for topical anesthesia
- no allergy to anticholinergic or adrenergic drugs
- able to understand and sign an informed consent
Key exclusion criteria (5 listed)
- history of uveitis
- iris neovascularization
- s/p iris surgery
- traumatic/uveitis induced cataract
- dialysis / abscence of zonules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior (more central) corneal paracentesis incision3 corneal paracentesis incisions will be located 1 mm anterior to the limbus. | Procedure or surgery | anterior corneal incision |
Primary outcome
the number of IFIS cases observed during operation.
Time frame: during the operations
1 secondary outcome
assessing the clinical grade of observed IFIS cases
Time frame: during the operations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
Related trials for Intraoperative Floppy Iris Syndrome
Not yet recruitingPhase 4
Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
Benign Prostatic Hyperplasia, Tamsulosin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior (more central) corneal paracentesis incision in people with Intraoperative Floppy Iris Syndrome, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of IFIS cases observed during operation. (time frame: during the operations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.