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
  Purpose

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.


Condition Intervention Phase
Cataracts
Device: DisCoVisc
Device: DuoVisc
Device: BioVisc
Device: Healon5
Device: Amvisc Plus
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 173
Study Start Date: May 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DisCoVisc
Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
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.
Active Comparator: DuoVisc
Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
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.
Active Comparator: BioVisc
Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Device: BioVisc
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Active Comparator: Healon5
AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Device: Healon5
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Active Comparator: Amvisc Plus
Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Device: Amvisc Plus
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

  Eligibility

Ages Eligible for Study:   49 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732225

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00732225     History of Changes
Other Study ID Numbers: M07-015
Study First Received: August 7, 2008
Results First Received: March 31, 2010
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
DisCoVisc OVD
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 July 24, 2014