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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 7, 2008
Last Updated Date	June 30, 2010
Start Date ^ICMJE	May 2007
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: August 8, 2008)	Endothelial cell loss. [ Time Frame: 2 months postoperative ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00732225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 30, 2010)	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 - Mild, slight localized or generalized edema - Moderate, significant localized or generalized edema - 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. 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 [ 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 to 5 cells - 6 to 15 cells - 16 to 30 cells - >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
Original Secondary Outcome Measures ^ICMJE (submitted: August 8, 2008)	Aqueous signs, intraocular pressure, surgeon survey [ Time Frame: 1 day postoperatively and operative ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	DisCoVisc Comparative Evaluation
Official Title ^ICMJE	A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Cataracts
Intervention ^ICMJE	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. 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. Device: BioVisc BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. Device: Healon5 Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. Device: Amvisc Plus Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Study Arm (s)	Active Comparator: DisCoVisc Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) Intervention: Device: DisCoVisc Active Comparator: DuoVisc Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) Intervention: Device: DuoVisc Active Comparator: BioVisc Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) Intervention: Device: BioVisc Active Comparator: Healon5 AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) Intervention: Device: Healon5 Active Comparator: Amvisc Plus Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) Intervention: Device: Amvisc Plus
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	173
Completion Date	Not Provided
Primary Completion Date	February 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	49 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00732225
Other Study ID Numbers ^ICMJE	M07-015
Has Data Monitoring Committee	No
Responsible Party	Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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