Intraoperative Floppy Iris Syndrome
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 3, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedResults Posted
Study results publicly available
August 4, 2010
CompletedAugust 10, 2010
August 1, 2010
10 months
July 3, 2008
September 9, 2009
August 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corneal Endothelial Cell Loss
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.
1 month
Secondary Outcomes (5)
Intraocular Pressure (IOP)
1 Day Postoperative
Aqueous Signs - Cells
1 Day Postoperative
Aqueous Signs - Flare
1 Day Postoperative
Aqueous Signs - Edema
1 Day Postoperative
Surgeon Survey
Time of Surgery
Study Arms (2)
DisCoVisc
ACTIVE COMPARATORAlcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Healon5
ACTIVE COMPARATORAbbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery
Interventions
Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.
Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.
Eligibility Criteria
You may qualify if:
- diagnosed with floppy iris syndrome
- operable bilateral cataracts
You may not qualify if:
- Intraocular Pressure (IOP) \> 21mmHg
- ocular inflammatory disease
- systemic or ocular diseases affecting Endothelial Cell Count
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erin Rogut
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 3, 2008
First Posted
July 8, 2008
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 10, 2010
Results First Posted
August 4, 2010
Record last verified: 2010-08