To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

NCT ID: NCT00763360

Last Updated: 2012-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31

Brief Summary

The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

DisCoVisc®

DisCoVisc® Ophthalmic Viscosurgical Device

Group Type: EXPERIMENTAL

DisCoVisc®

Intervention Type: DEVICE

Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure

Healon

Healon

Group Type: ACTIVE_COMPARATOR

Healon

Intervention Type: DRUG

Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure

Amvisc Plus

Amvisc Plus

Group Type: ACTIVE_COMPARATOR

Amvisc Plus

Intervention Type: DRUG

Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Interventions

DisCoVisc®

Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure

Intervention Type: DEVICE

Healon

Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure

Intervention Type: DRUG

Amvisc Plus

Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients able to understand and sign a document of informed consent;
• Patients aged ≥49 years with age-related cataract formation;
• Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
• Patients that have healthy eyes excluding the formation of cataract.

Exclusion Criteria

• pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
• A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
• Iris atrophy in the operative eye;
• Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
• Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
• Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
• Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
• Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
• Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
• Patients 48 years of age or younger;
• Proliferative diabetic retinopathy in the operative eye;
• Uncontrolled diabetes mellitus;
• Marfan's Syndrome;
• An ocular disease and/or condition that may compromise results;
• A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
• Lens for the correction of astigmatism may be performed;
• Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
• A non-functional fellow eye;
• Participation in any other clinical study within the 30 days before surgery

• Minimum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alcon Call Center

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

AUS-S-07-01

Identifier Type: -

Identifier Source: org_study_id