Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00762606|
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : July 8, 2011
Last Update Posted : October 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Procedure: Phacoemulsification cataract extraction surgery Procedure: Small incision cataract surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Active Comparator: Phaco
Cataract extraction surgery utilizing Phacoemulsification
Procedure: Phacoemulsification cataract extraction surgery
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
Active Comparator: SICS
Small incision cataract surgery (SICS)
Procedure: Small incision cataract surgery
Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
- Posterior Capsule Opacification Evaluation [ Time Frame: 12 months after surgery ]The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.
- Corneal Astigmatism [ Time Frame: 3 months after surgery ]Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
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): NCT00762606
|United States, Texas|
|Alcon Call Center|
|Fort Worth, Texas, United States, 76134|