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DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00712244
First received: July 7, 2008
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataract
 Device: DisCoVisc
Device: DuoVisc
Device: Healon5
Device: Amvisc Plus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: DisCoVisc Versus Competitor

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal Endothelial Cell Loss [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent Gain in Corneal Thickness. [ Time Frame: 1 week and month after surgery ] [ Designated as safety issue: No ]
    Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.

  • Aqueous Signs - Corneal Edema [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
    Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.

  • Aqueous Signs - Aqueous Flare [ Time Frame: 1 Day after Surgery ] [ Designated as safety issue: No ]
    Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - 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.

  • Aqueous Signs - Aqueous Cells [ Time Frame: 1 day after surgery ] [ Designated as safety issue: No ]
    Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.

  • Intraocular Pressure (IOP) [ Time Frame: 1 day after surgery ] [ Designated as safety issue: Yes ]
    Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.

  • Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
    Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.

  • Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
    Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.

  • Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
    Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.


Enrollment: 112
Study Start Date: October 2007
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DisCoVisc
Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.
 Device: DisCoVisc
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
Active Comparator: DuoVisc
Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.
 Device: DuoVisc
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
Active Comparator: Healon5
Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.
 Device: Healon5
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
Active Comparator: Amvisc Plus
Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.
 Device: Amvisc Plus
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • operable cataracts in at least one eye

Exclusion Criteria:

  • Endothelial Cell Count (ECC) ≤1500cells/mm2
  • Intraocular Pressure (IOP) > 21mm Hg
  • previous ocular inflammation
  • systemic or ocular conditions affecting corneal endothelium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712244

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: Rick Potvin, Alcon
ClinicalTrials.gov Identifier: NCT00712244     History of Changes
Other Study ID Numbers: M07-014
Study First Received: July 7, 2008
Results First Received: April 27, 2009
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Discovisc
Ophthalmic Viscosurgical Device

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013