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.
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|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 Cataract Surgery.|
- Endothelial Cell Count Change From Baseline [ Time Frame: one month ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
- Change in Corneal Thickness [ Time Frame: 1 month ] [ Designated as safety issue: No ]Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
- Corneal Clarity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2008|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
DisCoVisc® Ophthalmic Viscosurgical Device
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
Active Comparator: 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