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DisCoVisc Comparative Evaluation

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DisCoVisc
DuoVisc
BioVisc
Healon5
Amvisc Plus
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring DisCoVisc OVD, Ophthalmic Viscosurgical Device

Eligibility Criteria

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

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

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

DisCoVisc

DuoVisc

BioVisc

Healon5

Amvisc Plus

Arm Description

Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)

Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)

Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)

AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)

Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Outcomes

Primary Outcome Measures

Percent Loss of Endothelial Cells
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
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
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 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.
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 to 5 cells - 6 to 15 cells - 16 to 30 cells - >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 between 10 mmHg and 20 mmHg.
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
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
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
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

Full Information

First Posted
August 7, 2008
Last Updated
June 30, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00732225
Brief Title
DisCoVisc Comparative Evaluation
Official Title
A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (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 Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, 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
Cataracts
Keywords
DisCoVisc OVD, Ophthalmic Viscosurgical Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DisCoVisc
Arm Type
Active Comparator
Arm Description
Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
Arm Title
DuoVisc
Arm Type
Active Comparator
Arm Description
Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
Arm Title
BioVisc
Arm Type
Active Comparator
Arm Description
Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Arm Title
Healon5
Arm Type
Active Comparator
Arm Description
AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Arm Title
Amvisc Plus
Arm Type
Active Comparator
Arm Description
Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Intervention Type
Device
Intervention Name(s)
DisCoVisc
Intervention Description
DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Intervention Type
Device
Intervention Name(s)
DuoVisc
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
BioVisc
Intervention Description
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Intervention Type
Device
Intervention Name(s)
Healon5
Intervention Description
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Intervention Type
Device
Intervention Name(s)
Amvisc Plus
Intervention Description
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Primary Outcome Measure Information:
Title
Percent Loss of Endothelial Cells
Description
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.
Time Frame
2 months following surgery
Secondary Outcome Measure Information:
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 - Mild, slight localized or generalized edema - Moderate, significant localized or generalized edema - 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 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.
Time Frame
1 day following 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 to 5 cells - 6 to 15 cells - 16 to 30 cells - >30 cells
Time Frame
1 day following 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 between 10 mmHg and 20 mmHg.
Time Frame
1 day following surgery
Title
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Description
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.
Time Frame
Time of Surgery
Title
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification
Description
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
Time Frame
Time of Surgery
Title
Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion
Description
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
Time Frame
Time of Surgery

10. Eligibility

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

12. IPD Sharing Statement

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DisCoVisc Comparative Evaluation

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