Clinical Trial: Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study

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

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

Brief Summary: To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome: 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.


Original Primary Outcome: PCO evaluation; corneal Astigmatism [ Time Frame: PCR evalutaion: before surgery,6M and 12M after surgery; Corneal astigmatism: before surgery,3M after surgery ]

Current Secondary Outcome: 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.


Original Secondary Outcome: Contrast sensitivity; IOP [ Time Frame: Contrast sensitivity:3M,6M after surgery; IOP:before surgery,1D and 2W after surgery ]

Information By: Alcon Research

Dates:
Date Received: September 26, 2008
Date Started: September 2008
Date Completion:
Last Updated: October 26, 2012
Last Verified: August 2011