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DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
DisCoVisc
DuoVisc
Healon5
Amvisc Plus
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Discovisc, Ophthalmic Viscosurgical Device

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact Alcon Call Center for Study Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

DisCoVisc

DuoVisc

Healon5

Amvisc Plus

Arm Description

Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.

Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.

Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.

Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.

Outcomes

Primary Outcome Measures

Corneal Endothelial Cell Loss
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.
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
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
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
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)
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
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
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
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.

Full Information

First Posted
July 7, 2008
Last Updated
September 10, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00712244
Brief Title
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
Official Title
DisCoVisc Versus Competitor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Discovisc, Ophthalmic Viscosurgical Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DisCoVisc
Arm Type
Active Comparator
Arm Description
Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.
Arm Title
DuoVisc
Arm Type
Active Comparator
Arm Description
Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.
Arm Title
Healon5
Arm Type
Active Comparator
Arm Description
Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.
Arm Title
Amvisc Plus
Arm Type
Active Comparator
Arm Description
Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.
Intervention Type
Device
Intervention Name(s)
DisCoVisc
Intervention Description
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
Intervention Type
Device
Intervention Name(s)
DuoVisc
Intervention Description
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Healon5
Intervention Description
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Amvisc Plus
Intervention Description
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.
Primary Outcome Measure Information:
Title
Corneal Endothelial Cell Loss
Description
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.
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Percent Gain in Corneal Thickness.
Description
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.
Time Frame
1 week and month after surgery
Title
Aqueous Signs - Corneal Edema
Description
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.
Time Frame
1 day after surgery
Title
Aqueous Signs - Aqueous Flare
Description
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.
Time Frame
1 Day after Surgery
Title
Aqueous Signs - Aqueous Cells
Description
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.
Time Frame
1 day after surgery
Title
Intraocular Pressure (IOP)
Description
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.
Time Frame
1 day after surgery
Title
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Description
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.
Time Frame
Time of surgery
Title
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
Description
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.
Time Frame
Time of Surgery
Title
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
Description
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.
Time Frame
Time of Surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Contact Alcon Call Center for Study Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

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