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

Primary Purpose

Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Malyugin Ring
Iris hooks
standard OVD
OVD
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VIROS- Vienna Institute for Research in Ocular Surgery - Department of Ophthalmology, Hanusch Hospital ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

standard OVD

Iris hooks

Malyugin Ring

OVD

Arm Description

Outcomes

Primary Outcome Measures

Mean difference in flare (pre-operatively to 1 day post-operatively) between the OVD and the device group

Secondary Outcome Measures

Full Information

First Posted
January 25, 2013
Last Updated
January 25, 2013
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT01778959
Brief Title
Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery
Acronym
IFIS
Official Title
Methods to Manage Intra-operative Floppy-iris Syndrome and Poor Pupil Dilation in Cataract Surgery: an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Management of Intraoperative Floppy-iris Syndrome and Small Pupils With Different Mechanical Devices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard OVD
Arm Type
Active Comparator
Arm Title
Iris hooks
Arm Type
Active Comparator
Arm Title
Malyugin Ring
Arm Type
Active Comparator
Arm Title
OVD
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Malyugin Ring
Intervention Description
insertion of a Malyugin Ring to stabilite the pupil during cataract surgery
Intervention Type
Device
Intervention Name(s)
Iris hooks
Intervention Description
insertion of iris retractors to stabilize the pupil during cataract surgery
Intervention Type
Device
Intervention Name(s)
standard OVD
Intervention Description
use of a standard cohesive OVD during cataract surgery
Intervention Type
Device
Intervention Name(s)
OVD
Intervention Description
use of a highly cohesive OVD during cataract surgery
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, MD, MBA
Phone
+43 1 91021
Ext
84611
Email
oliver@findl.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA
Organizational Affiliation
VIROS- Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIROS- Vienna Institute for Research in Ocular Surgery - Department of Ophthalmology, Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD; MBA
Phone
+43 1 91021 84611
Email
oliver@findl.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
First Name & Middle Initial & Last Name & Degree
Sophie Tatzreiter, MD
First Name & Middle Initial & Last Name & Degree
Maria Weber, MD

12. IPD Sharing Statement

Learn more about this trial

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

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