Clinical Trial: 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.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome:

• Endothelial Cell Count Change From Baseline [ Time Frame: one month ]
  Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
• Investigator Reported Space Maintenance [ Time Frame: During surgical procedure ]
  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.

Original Primary Outcome: endothelial cell count [ Time Frame: one month ]

Current Secondary Outcome:

• Change in Corneal Thickness [ Time Frame: 1 month ]
  Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
• Corneal Clarity [ Time Frame: 2 weeks ]
  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.

Original Secondary Outcome: Investigator reported space maintenance [ Time Frame: During surgical procedure ]

Information By: Alcon Research

Dates:
Date Received: September 26, 2008
Date Started: May 2008
Date Completion:
Last Updated: December 20, 2011
Last Verified: December 2011