DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
DisCoVisc Versus Competitor
1 other identifier
interventional
112
1 country
1
Brief Summary
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedResults Posted
Study results publicly available
June 16, 2009
CompletedSeptember 14, 2010
September 1, 2010
1.5 years
July 7, 2008
April 27, 2009
September 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Corneal Endothelial Cell Loss
Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.
1 month after surgery
Secondary Outcomes (8)
Percent Gain in Corneal Thickness.
1 week and month after surgery
Aqueous Signs - Corneal Edema
1 day after surgery
Aqueous Signs - Aqueous Flare
1 Day after Surgery
Aqueous Signs - Aqueous Cells
1 day after surgery
Intraocular Pressure (IOP)
1 day after surgery
- +3 more secondary outcomes
Study Arms (4)
DisCoVisc
ACTIVE COMPARATORUse of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.
DuoVisc
ACTIVE COMPARATORUse of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.
Healon5
ACTIVE COMPARATORUse of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.
Amvisc Plus
ACTIVE COMPARATORUse of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.
Interventions
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.
Eligibility Criteria
You may qualify if:
- operable cataracts in at least one eye
You may not qualify if:
- Endothelial Cell Count (ECC) ≤1500cells/mm2
- Intraocular Pressure (IOP) \> 21mm Hg
- previous ocular inflammation
- systemic or ocular conditions affecting corneal endothelium
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
- Alcon Clinical
- 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 7, 2008
First Posted
July 9, 2008
Study Start
October 1, 2007
Primary Completion
April 1, 2009
Last Updated
September 14, 2010
Results First Posted
June 16, 2009
Record last verified: 2010-09