DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Cataract Clinical Trial

Official title:

DisCoVisc Versus Competitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712244
• Other study ID #: M07-014
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: September 10, 2010
• Start date: October 2007

Study information

• Verified date: September 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• DisCoVisc
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.
• DuoVisc
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.
• Healon5
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.
• Amvisc Plus
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Study Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after surgery	No
Secondary	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.	1 week and month after surgery	No
Secondary	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.	1 day after surgery	No
Secondary	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.	1 Day after Surgery	No
Secondary	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.	1 day after surgery	No
Secondary	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.	1 day after surgery	Yes
Secondary	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.	Time of surgery	No
Secondary	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.	Time of Surgery	No
Secondary	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.	Time of Surgery	No