DisCoVisc Comparative Evaluation

Phase 3

Completed

• Conditions: Cataracts
• Interventions: Device: DisCoVisc; Device: DuoVisc; Device: BioVisc; Device: Healon5; Device: Amvisc Plus

• Registration Number: NCT00732225
• Lead Sponsor: Alcon Research

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 available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-02
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Results First Submitted: 2010-03-31
• Status Verified: 2010-06
• Results First Submitted QC: 2010-06-30
• Last Update Submitted: 2010-06-30
• Results First Posted: 2010-07-30
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DisCoVisc	DisCoVisc	Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc	DuoVisc	Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc	BioVisc	Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5	Healon5	AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
Amvisc Plus	Amvisc Plus	Bausch \& Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Primary Outcome Measures

Name	Time	Method
Percent Loss of Endothelial Cells	2 months following surgery	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

Name	Time	Method
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 following 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 with 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 the 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 following 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 to 30 cells; 4. - \>30 cells
Intraocular Pressure (IOP)	1 day following surgery	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 of Surgery	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 of Surgery	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 of Surgery	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

Trial Locations

Locations (1)

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