Back to resultsPhaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phacoemulsification cataract extraction surgery
Small incision cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract
Eligibility Criteria
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
Sites / Locations
- Alcon Call Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phaco
SICS
Arm Description
Cataract extraction surgery utilizing Phacoemulsification
Small incision cataract surgery (SICS)
Outcomes
Primary Outcome Measures
Posterior Capsule Opacification Evaluation
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
Corneal Astigmatism
Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762606
Brief Title
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phaco
Arm Type
Active Comparator
Arm Description
Cataract extraction surgery utilizing Phacoemulsification
Arm Title
SICS
Arm Type
Active Comparator
Arm Description
Small incision cataract surgery (SICS)
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification cataract extraction surgery
Intervention Description
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
Intervention Type
Procedure
Intervention Name(s)
Small incision cataract surgery
Intervention Description
Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
Primary Outcome Measure Information:
Title
Posterior Capsule Opacification Evaluation
Description
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.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Corneal Astigmatism
Description
Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alcon Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
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