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

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

Official Title
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A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Phacoemulsification cataract extraction surgery
* Procedure: Small incision cataract surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phaco<br>Cataract extraction surgery utilizing Phacoemulsification | Procedure: Phacoemulsification cataract extraction surgery<br>* Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)<br>|
| Active Comparator: SICS<br>Small incision cataract surgery (SICS) | Procedure: Small incision cataract surgery<br>* Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Astigmatism | Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract