Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.
1 other identifier
interventional
106
1 country
1
Brief Summary
To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
July 8, 2011
CompletedOctober 31, 2012
August 1, 2011
1.7 years
September 26, 2008
June 7, 2011
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months after surgery
Secondary Outcomes (1)
Corneal Astigmatism
3 months after surgery
Study Arms (2)
Phaco
ACTIVE COMPARATORCataract extraction surgery utilizing Phacoemulsification
SICS
ACTIVE COMPARATORSmall incision cataract surgery (SICS)
Interventions
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Call Center
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 31, 2012
Results First Posted
July 8, 2011
Record last verified: 2011-08