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.
|ClinicalTrials.gov Identifier: NCT00763360|
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : January 24, 2012
Last Update Posted : January 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: DisCoVisc® Drug: Healon Drug: Amvisc Plus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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.|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||September 2010|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763360
|United States, Texas|
|Alcon Call Center|
|Fort Worth, Texas, United States, 76134|