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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Phacoemulsification cataract extraction surgery; Procedure: Small incision cataract surgery

• Registration Number: NCT00762606
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-07
• Results First Submitted QC: 2011-06-07
• Results First Posted: 2011-07-08
• Status Verified: 2011-08
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);
• Pupil dilation ≧7 mm after mydrisis;
• Patient undergoing cataract surgery for the first eye;
• VA prognosis ≧6/12

Exclusion Criteria

• Patients with history of ocular pathology or diabetic retinopathy;
• Patients with traumatic, subluxated and posterior polar cataract;
• Patients had ocular surgery in the past 6 months;
• Patients with significant intra-operative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phaco	Phacoemulsification cataract extraction surgery	Cataract extraction surgery utilizing Phacoemulsification
SICS	Small incision cataract surgery	Small incision cataract surgery (SICS)

Primary Outcome Measures

Name	Time	Method
Posterior Capsule Opacification Evaluation	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.

Secondary Outcome Measures

Name	Time	Method
Corneal Astigmatism	3 months after surgery	Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.

Trial Locations

Locations (1)

Alcon Call Center; 🇺🇸 Fort Worth, Texas, United States