Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical DevicesIFISNCT01778959
Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery
A study testing Malyugin Ring, Iris hooks and standard OVD in people with Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Cataract surgery is one of the most frequently performed surgeries worldwide and complications are rare. However, there are factors that increase the risk of complications, such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices
- What is being tested?
- Malyugin Ring, Iris hooks and standard OVD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2012to Dec 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract
- Age 21 and older
- written informed consent prior to surgery
- Small pupil group: Patients with a pupil size below 4.0 mm after pharmacological dilation with tropicamide 1% and phenylephrine 2.5% gtt as used routinely for pupil dilation,
- IFIS group: Patients, who currently are or have been treated with Alpha-adrenergic receptor antagonists (Tamsulosin- i.e. Alna ret.®)
Who cannot join
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Traumatic cataract
- History of uveitis
- Any ophthalmic pathology that could compromise the measurements
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
VIROS- Vienna Institute for Research in Ocular Surgery - Department of Ophthalmology, Hanusch Hospital Vienna
Vienna, State of Vienna, 1140
Oliver Findl, MD; MBA, +43 1 91021 84611, oliver@findl.at
Nino Hirnschall, MD
About this study
Official title: Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery: an Exploratory Study
Cataract surgery is one of the most frequently performed surgeries worldwide and complications are rare. However, there are factors that increase the risk of complications, such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for iris prolapse towards the phacoemulsification tip as well as towards the incisions and progressive intra-operative pupil constriction.
Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it is of high importance to identify patients prior to surgery, who are treated with alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil dilation. Some methods, such as intracameral injection of phenylephrine is only sufficient in a few cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another pharmacological method is the use of atropine drops pre-operatively, but this method did not show to sufficiently reduce IFIS.4
Read more
Different methods were shown to reduce intra-operative problems due to IFIS/small pupil size:
The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to viscodilate the pupil and by resting on the iris during the entire phacoemulsification procedure reduce the risk of iris prolapsing towards the incisions. This method is more dependent on a central phacoemulsification technique and low fluidic parameters to allow the OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil stretching with 2 instruments can be used additively.
Another option to stabilize the pupil size is the use of mechanical pupil expansion devices, such as
- Iris retractors - these devices are routinely used to dilate the pupil intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of overstretching is small.8
- Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil margin with an injector through the main incision. It eliminates the need of additional incisions and saves time.9
Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a viscoadaptive OVD.
- Conditions
- Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices
- Being tested
- Malyugin Ring, Iris hooks, standard OVD, OVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malyugin RingDevice
insertion of a Malyugin Ring to stabilite the pupil during cataract surgery
Iris hooksDevice
insertion of iris retractors to stabilize the pupil during cataract surgery
standard OVDDevice
use of a standard cohesive OVD during cataract surgery
OVDDevice
use of a highly cohesive OVD during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| standard OVD | Active comparator | Not described Receives: Device: standard OVD |
| Iris hooks | Active comparator | Not described Receives: Device: Iris hooks |
| Malyugin Ring | Active comparator | Not described Receives: Device: Malyugin Ring |
| OVD | Active comparator | Not described Receives: Device: OVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in flare (pre-operatively to 1 day post-operatively) between the OVD and the device group
Measured: pre-operatively to 1 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical DevicesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, MBA, Principal investigator, VIROS- Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778959
- Sponsor's protocol ID
- IFIS
- Acronym
- IFIS
- Status last verified
- Jan 2013
- First submitted
- 25 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery: an Exploratory Study
- ClinicalTrials.gov ID
- NCT01778959
- Acronym / sponsor ID
- IFIS / IFIS
- Conditions
- Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Jan 2013 (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.
Cataract surgery is one of the most frequently performed surgeries worldwide and complications are rare. However, there are factors that increase the risk of complications, such as poor pupil dilation and intra-operative floppy iris syndrome (IFIS). Reasons for a small pupil size are pseudoexfoliation syndrome (PXF) syndrome, uveitis or synechia and the use of pilocarpin drops. IFIS is a syndrome usually caused by systemic alpha1-blockers (foremost tamsulosin) used to treat benign prostatic hyperplasia.1,2 As described by Chang and Campbell3 IFIS is characterized by billowing of a flaccid iris stroma, a propensity for iris prolapse towards the phacoemulsification tip as well as towards the incisions and progressive intra-operative pupil constriction.
Stopping tamsulosin pre-operatively did not show to effectively prevent IFIS.4,5 However, it is of high importance to identify patients prior to surgery, who are treated with alpha1-blockers, or patients with a small pupil size and poor pharmacological pupil dilation. Some methods, such as intracameral injection of phenylephrine is only sufficient in a few cases 6, and a disadvantage is the risk of a hypertensive episode.7 Another pharmacological method is the use of atropine drops pre-operatively, but this method did not show to sufficiently reduce IFIS.4
Different methods were shown to reduce intra-operative problems due to IFIS/small pupil size:
The use of highly cohesive ophthalmic viscosurgical devices (OVD), also called viscoadaptives, such as sodium hyaluronate (e.g. AMO Healon5 or Croma Eyefill H.D.) help to viscodilate the pupil and by resting on the iris during the entire phacoemulsification procedure reduce the risk of iris prolapsing towards the incisions. This method is more dependent on a central phacoemulsification technique and low fluidic parameters to allow the OVD to stay on the iris during the entire procedure.8 In case of a small pupil, pupil stretching with 2 instruments can be used additively.
Another option to stabilize the pupil size is the use of mechanical pupil expansion devices, such as
- Iris retractors - these devices are routinely used to dilate the pupil intra-operatively. Typically, 4 or 5 iris retractors, also called iris hooks, are inserted through 4-5 incisions. Usually, the IFIS pupil is very elastic and the risk of overstretching is small.8
- Pupil expansion rings, such as the Malyugin ring. This ring is placed on the pupil margin with an injector through the main incision. It eliminates the need of additional incisions and saves time.9
Rationale To compare different methods to manage IFIS and poor pupil dilation in cataract surgery: a pupil expansion ring (Malyugin Ring), iris retractors (iris hooks) and a viscoadaptive OVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| standard OVD | Active comparator | Device: standard OVD |
| Iris hooks | Active comparator | Device: Iris hooks |
| Malyugin Ring | Active comparator | Device: Malyugin Ring |
| OVD | Active comparator | Device: OVD |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age-related cataract
- Age 21 and older
- written informed consent prior to surgery
- Small pupil group: Patients with a pupil size below 4.0 mm after pharmacological dilation with tropicamide 1% and phenylephrine 2.5% gtt as used routinely for pupil dilation,
- IFIS group: Patients, who currently are or have been treated with Alpha-adrenergic receptor antagonists (Tamsulosin- i.e. Alna ret.®)
Key exclusion criteria (4 listed)
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- Traumatic cataract
- History of uveitis
- Any ophthalmic pathology that could compromise the measurements
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 |
|---|---|---|
| Malyugin Ringinsertion of a Malyugin Ring to stabilite the pupil during cataract surgery | Device | Malyugin Ring |
| Iris hooksinsertion of iris retractors to stabilize the pupil during cataract surgery | Device | Iris hooks |
| standard OVDuse of a standard cohesive OVD during cataract surgery | Device | standard OVD |
| OVDuse of a highly cohesive OVD during cataract surgery | Device | OVD |
Primary outcome
Mean difference in flare (pre-operatively to 1 day post-operatively) between the OVD and the device group
Time frame: pre-operatively to 1 day postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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.
Oliver Findl, MD, MBA principal investigator
VIROS- Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malyugin Ring, Iris hooks and standard OVD in people with Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 4 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 29 Jan 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 Austria. 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?
Contact Oliver Findl, MD, MBA (+43 1 91021 ext. 84611, oliver@findl.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in flare (pre-operatively to 1 day post-operatively) between the OVD and the device group (time frame: pre-operatively to 1 day postoperatively). 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 29 Jan 2013.