DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: DisCoVisc; Device: DuoVisc; Device: Healon5; Device: Amvisc Plus

• Registration Number: NCT00712244
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Primary Completion: 2009-04
• Results First Submitted: 2009-04-27
• Results First Submitted QC: 2009-04-27
• Results First Posted: 2009-06-16
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DisCoVisc	DisCoVisc	Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.
DuoVisc	DuoVisc	Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.
Healon5	Healon5	Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.
Amvisc Plus	Amvisc Plus	Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.

Primary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Loss	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 Outcome Measures

Name	Time	Method
Percent Gain in Corneal Thickness.	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.
Aqueous Signs - Corneal Edema	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.
Aqueous Signs - Aqueous Flare	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.
Aqueous Signs - Aqueous Cells	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.
Intraocular Pressure (IOP)	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.
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy	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.
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification	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.
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Study Locations; 🇺🇸 Fort Worth, Texas, United States