Intraoperative Floppy Iris Syndrome

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00711347
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
10
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: DisCoVisc
  • Device: Healon5
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: DisCoVisc

Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Device: DisCoVisc
Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.

Active Comparator: Healon5

Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery

Device: Healon5
Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Outcome Measures

Primary Outcome Measures

  1. Corneal Endothelial Cell Loss [1 month]

    Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.

Secondary Outcome Measures

  1. Intraocular Pressure (IOP) [1 Day Postoperative]

    Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.

  2. Aqueous Signs - Cells [1 Day Postoperative]

    Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells

  3. Aqueous Signs - Flare [1 Day Postoperative]

    Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye. Mild-Flare visible against dark papillary background but not visible against iris background. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.

  4. Aqueous Signs - Edema [1 Day Postoperative]

    Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none = mild - slight localized or generalized edema = moderate - significant localized or generalized edema = severe - advanced localized or generalized edema

  5. Surgeon Survey [Time of Surgery]

    Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • diagnosed with floppy iris syndrome

  • operable bilateral cataracts

Exclusion Criteria:
  • Intraocular Pressure (IOP) > 21mmHg

  • ocular inflammatory disease

  • systemic or ocular diseases affecting Endothelial Cell Count

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Contact Alcon Call Center for Study LocationsFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00711347
Other Study ID Numbers:
  • M07-013
First Posted:
Jul 8, 2008
Last Update Posted:
Aug 10, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsPatients were scheduled for routine, primary, bilateral cataract extraction with subsequent insertion of an intraocular lens implant and demonstrating miotic/small pupils or intraoperative floppy iris syndrome. Additionally patients were free of ocular co-morbidities that may affect results.
Pre-assignment DetailDuring the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. Patients were randomized (Excel based schedule) based on enrollment order.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Period Title: Overall Study
STARTED1414
COMPLETED1414
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleDisCoViscHealon5Total
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgeryTotal of all reporting groups
Overall Participants141428
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
1
7.1%
1
7.1%
2
7.1%
>=65 years
13
92.9%
13
92.9%
26
92.9%
Sex: Female, Male (Count of Participants)
Female
1
7.1%
2
14.3%
3
10.7%
Male
13
92.9%
12
85.7%
25
89.3%

Outcome Measures

1. Primary Outcome
TitleCorneal Endothelial Cell Loss
DescriptionEndothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.
Time Frame1 month

Outcome Measure Data

Analysis Population Description
14 patients/28 eyes in each group.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Mean (Standard Deviation) [Percent change]
9.85
(14.07)
-3.68
(16.52)
2. Secondary Outcome
TitleIntraocular Pressure (IOP)
DescriptionIntraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.
Time Frame1 Day Postoperative

Outcome Measure Data

Analysis Population Description
14 patients/28 eyes in each group.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Mean (Standard Deviation) [mmHg]
16.93
(3.67)
20.29
(11.19)
3. Secondary Outcome
TitleAqueous Signs - Cells
DescriptionAqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells
Time Frame1 Day Postoperative

Outcome Measure Data

Analysis Population Description
14 patients/28 eyes in each group.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Mean (Standard Deviation) [Units on a scale]
0.93
(1.00)
1.14
(0.95)
4. Secondary Outcome
TitleAqueous Signs - Flare
DescriptionAqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye. Mild-Flare visible against dark papillary background but not visible against iris background. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.
Time Frame1 Day Postoperative

Outcome Measure Data

Analysis Population Description
14 patients/28 eyes in each group.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Mean (Standard Deviation) [Units on a scale]
0.43
(0.51)
0.69
(0.48)
5. Secondary Outcome
TitleAqueous Signs - Edema
DescriptionAqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none = mild - slight localized or generalized edema = moderate - significant localized or generalized edema = severe - advanced localized or generalized edema
Time Frame1 Day Postoperative

Outcome Measure Data

Analysis Population Description
14 patients/28 eyes in each group.
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Mean (Standard Deviation) [Units on a scale]
0.57
(0.65)
0.79
(0.89)
6. Secondary Outcome
TitleSurgeon Survey
DescriptionSurvey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective
Time FrameTime of Surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
Measure Participants1414
Surgeon Survey: Overall Surgical Difficulty
1.9
(0.8)
2.5
(0.9)
Surgeon Survey: Satisfaction with Performance
4.6
(0.5)
3.6
(1.0)
Surgeon Survey: Ability to Expand Pupil
2.9
(0.4)
2.9
(0.3)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleDisCoViscHealon5
Arm/Group DescriptionAlcon's DisCoVisc used at time of surgeryAbbot Medical Optics (AMO) Healon5 used at time of surgery
All Cause Mortality
DisCoViscHealon5
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
DisCoViscHealon5
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/14 (0%) 0/14 (0%)
Other (Not Including Serious) Adverse Events
DisCoViscHealon5
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/14 (0%) 0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.

Results Point of Contact

Name/TitleErin Rogut
OrganizationAlcon Research, Ltd.
Phone813-426-4036
EmailErin.Rogut@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00711347
Other Study ID Numbers:
  • M07-013
First Posted:
Jul 8, 2008
Last Update Posted:
Aug 10, 2010
Last Verified:
Aug 1, 2010