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DisCoVisc Comparative Evaluation

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00732225
First received: August 7, 2008
Last updated: June 30, 2010
Last verified: June 2010

August 7, 2008
June 30, 2010
May 2007
February 2008   (final data collection date for primary outcome measure)
Percent Loss of Endothelial Cells [ Time Frame: 2 months following surgery ] [ Designated as safety issue: No ]
Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.
Endothelial cell loss. [ Time Frame: 2 months postoperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732225 on ClinicalTrials.gov Archive Site
  • 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 following 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 with 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 the 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 following 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 to 30 cells
    4. - >30 cells
  • Intraocular Pressure (IOP) [ Time Frame: 1 day following 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 between 10 mmHg and 20 mmHg.
  • Physician 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 patient'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.
  • Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
    Surgeon reporting of Anterior Chamber Dome Maintenance of a patient'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
  • Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
    Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance
Aqueous signs, intraocular pressure, surgeon survey [ Time Frame: 1 day postoperatively and operative ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
DisCoVisc Comparative Evaluation
A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

A comparison of the ability of DisCoVisc to that of other Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, Healon5®, or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cataracts
  • Device: DisCoVisc
    DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
  • Device: DuoVisc
    DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
  • Device: BioVisc
    BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
  • Device: Healon5
    Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
  • Device: Amvisc Plus
    Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
  • Active Comparator: DisCoVisc
    Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
    Intervention: Device: DisCoVisc
  • Active Comparator: DuoVisc
    Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
    Intervention: Device: DuoVisc
  • Active Comparator: BioVisc
    Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
    Intervention: Device: BioVisc
  • Active Comparator: Healon5
    AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
    Intervention: Device: Healon5
  • Active Comparator: Amvisc Plus
    Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
    Intervention: Device: Amvisc Plus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
Not Provided
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unilateral operable cataracts

Exclusion Criteria:

  • Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2
  • Intraocular Pressure (IOP) > 21
  • History of ocular inflammation
  • Systemic or ocular diseases affecting corneal endothelium
Both
49 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00732225
M07-015
No
Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP