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

Alcon Research106 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

106

Conditions

Cataract

Interventions

Phacoemulsification cataract extraction surgeryPROCEDURE

Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)

Small incision cataract surgeryPROCEDURE

Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Alcon Call Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months after surgery

Secondary Outcomes

Corneal Astigmatism

Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.

Time frame: 3 months after surgery

Data from ClinicalTrials.gov

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