Intraoperative Floppy Iris Syndrome - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00711347

Purpose

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	Intervention	Phase
Cataract Intraoperative Floppy Iris Syndrome	Device: DisCoVisc	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Corneal Endothelial Cell Loss [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraocular pressure [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	June 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Alcon's DisCoVisc OVD used at time of surgery	Device: DisCoVisc Alcon's DisCoVisc OVD (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
2: Active Comparator AMO's Healon5 used at time of surgery	Device: DisCoVisc Alcon's DisCoVisc OVD (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

diagnosed with floppy iris syndrome; operable bilateral cataracts

Exclusion Criteria:

ECC ≥1500cells/mm2; IOP > 21mmHg; ocular inflammatory disease; systemic or ocular diseases affecting ECC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711347

Locations

United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Laboratories, Inc. ( Rick Potvin )
Study ID Numbers:	M07-013
Study First Received:	July 3, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00711347 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Discovisc
Ophthalmic Visco Surgical Device

Study placed in the following topic categories:

Chondroitin
Hyaluronic Acid
Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Eye Diseases

Cataract
Syndrome
Lens Diseases

ClinicalTrials.gov processed this record on September 11, 2009