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Sponsored by: |
Alcon Research |
---|---|
Information provided by: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00763360 |
The objective of the study is to assess how DisCoVisc OVD compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
Condition | Intervention | Phase |
---|---|---|
Cataract |
Device: DisCoVisc® OVD Drug: Healon Drug: Amvisc Plus |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
DisCoVisc®
|
Device: DisCoVisc® OVD
Injection into the anterior chamber prior to and throughout the cataract surgery procedure
|
2: Active Comparator
Healon
|
Drug: Healon
Injection into the anterior chamber prior to and throughout the cataract surgery procedure
|
3: Active Comparator
Amvisc Plus
|
Drug: Amvisc Plus
Injection into the anterior chamber prior to and throughout the cataract surgery procedure
|
Ages Eligible for Study: | 49 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Alcon Laboratories (Australia) Pty Ltd ( Robert Kitchen, Director of Scientific Affairs ) |
Study ID Numbers: | AUS-S-07-01 |
Study First Received: | September 26, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00763360 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Cataract |
Immunologic Factors Hyaluronic Acid Eye Diseases Cataract |
Adjuvants, Immunologic Benzocaine Lens Diseases |
Immunologic Factors Hyaluronic Acid Eye Diseases Cataract |
Physiological Effects of Drugs Adjuvants, Immunologic Lens Diseases Pharmacologic Actions |