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.

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: DisCoVisc®; Drug: Healon; Drug: Amvisc Plus

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Alcon Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DisCoVisc®; DisCoVisc® Ophthalmic Viscosurgical Device	Device: DisCoVisc®; Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
Active Comparator: Healon	Drug: Healon; Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
Active Comparator: Amvisc Plus	Drug: Amvisc Plus; Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Corneal Thickness	Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.	1 month
Corneal Clarity	Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.	2 weeks

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): January 24, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: AUS-S-07-01