Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery (IFIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vienna Institute for Research in Ocular Surgery
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT01778959
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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

  1. 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
  2. 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.


Condition Intervention
Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices
Device: Malyugin Ring
Device: Iris hooks
Device: standard OVD
Device: OVD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery: an Exploratory Study

Resource links provided by NLM:


Further study details as provided by Vienna Institute for Research in Ocular Surgery:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard OVD Device: standard OVD
use of a standard cohesive OVD during cataract surgery
Active Comparator: Iris hooks Device: Iris hooks
insertion of iris retractors to stabilize the pupil during cataract surgery
Active Comparator: Malyugin Ring Device: Malyugin Ring
insertion of a Malyugin Ring to stabilite the pupil during cataract surgery
Active Comparator: OVD Device: OVD
use of a highly cohesive OVD during cataract surgery

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.®)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778959

Contacts
Contact: Oliver Findl, MD, MBA +43 1 91021 ext 84611 oliver@findl.at

Locations
Austria
VIROS- Vienna Institute for Research in Ocular Surgery - Department of Ophthalmology, Hanusch Hospital Vienna Recruiting
Vienna, Austria, 1140
Contact: Oliver Findl, MD; MBA    +43 1 91021 84611    oliver@findl.at   
Sub-Investigator: Nino Hirnschall, MD         
Sub-Investigator: Sophie Tatzreiter, MD         
Sub-Investigator: Maria Weber, MD         
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
Principal Investigator: Oliver Findl, MD, MBA VIROS- Vienna Institute for Research in Ocular Surgery
  More Information

No publications provided

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Prim. Univ.-Prof. Oliver Findl, MD, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT01778959     History of Changes
Other Study ID Numbers: IFIS
Study First Received: January 25, 2013
Last Updated: January 25, 2013
Health Authority: Austria: Federal Ministry for Health Family and Youth

Additional relevant MeSH terms:
Mydriasis
Syndrome
Disease
Eye Diseases
Pathologic Processes
Pupil Disorders

ClinicalTrials.gov processed this record on November 24, 2014