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OpenTrials
Completed

NCT Number: NCT00712244

DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Study 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

  • 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

Treatment and study plan

DiscoVisc

Device

Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.

DuoVisc

Device

Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.

Healon5

Device

Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.

Amvisc Plus

Device

Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

Primary outcomes

  1. Corneal Endothelial Cell Loss

    Time frame: 1 month after surgery

    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 outcomes

  1. Percent Gain in Corneal Thickness.

    Time frame: 1 week and month after surgery

    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.

  2. 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; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.

  3. Aqueous Signs - Aqueous Flare

    Time frame: 1 Day after 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 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.

  4. Aqueous Signs - Aqueous Cells

    Time frame: 1 day after surgery

    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.

  5. Intraocular Pressure (IOP)

    Time frame: 1 day after surgery

    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.

  6. Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy

    Time frame: Time of surgery

    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.

  7. Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification

    Time frame: Time of Surgery

    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.

  8. Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion

    Time frame: Time of Surgery

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

DisCoVisc Versus Competitor

Important dates

Study start
2007
Primary completion
2009
First posted
Jul 9, 2008
Registry last updated
Sep 14, 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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