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.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|