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.

NCT00763360 | Completed Phase 4 Results

• 1 other identifier: AUS-S-07-01
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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

Keywords

Cataract

Outcome Measures

Primary Outcomes (2)

• Endothelial Cell Count Change From Baseline

  Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.

  one month

• Investigator Reported Space Maintenance

  Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.

  During surgical procedure

Secondary Outcomes (2)

• Change in Corneal Thickness

  1 month

• Corneal Clarity

  2 weeks

Study Arms (3)

DisCoVisc®

EXPERIMENTAL

DisCoVisc® Ophthalmic Viscosurgical Device

Device: DisCoVisc®

Healon

ACTIVE COMPARATOR

Healon

Drug: Healon

Amvisc Plus

ACTIVE COMPARATOR

Amvisc Plus

Drug: Amvisc Plus

Interventions

DisCoVisc® DEVICE

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

DisCoVisc®

Healon DRUG

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

Healon

Amvisc Plus DRUG

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

Amvisc Plus

Eligibility Criteria

• Age: 49 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Last Updated: January 24, 2012
• Results First Posted: January 24, 2012

Record last verified: 2011-12

Locations

US (1)