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OpenTrials
Completed

NCT Number: NCT00732225

DisCoVisc Comparative Evaluation

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

49 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DiscoVisc

Device

DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

DuoVisc

Device

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.

BioVisc

Device

BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Healon5

Device

Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Amvisc Plus

Device

Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Primary outcomes

  1. Percent Loss of Endothelial Cells

    Time frame: 2 months following surgery

    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 outcomes

  1. Aqueous Signs - Corneal Edema

    Time frame: 1 day after surgery

    Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:

    0 - None

    • - Mild, slight localized or generalized edema
    • - Moderate, significant localized or generalized edema
    • - Severe, advanced localized or generalized edema

  2. Aqueous Signs - Aqueous Flare

    Time frame: 1 day following surgery

    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.

    • Mild: Flare visible against dark papillary background but not visible against iris background.
    • Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.
    • 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.

  3. Aqueous Signs - Aqueous Cells

    Time frame: 1 day following surgery

    Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:

    0 - None

    • - 1 to 5 cells
    • - 6 to 15 cells
    • - 16 to 30 cells
    • - >30 cells

  4. Intraocular Pressure (IOP)

    Time frame: 1 day following surgery

    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.

  5. Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy

    Time frame: Time of Surgery

    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.

  6. Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification

    Time frame: Time of Surgery

    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

  7. Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion

    Time frame: Time of Surgery

    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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

Important dates

Study start
2007
Primary completion
2008
First posted
Aug 11, 2008
Registry last updated
Jul 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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