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

NCT ID: NCT00762606

Last Updated: 2012-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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Conditions

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Cataract

Keywords

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Phaco

Cataract extraction surgery utilizing Phacoemulsification

Group Type ACTIVE_COMPARATOR

Phacoemulsification cataract extraction surgery

Intervention Type PROCEDURE

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

SICS

Small incision cataract surgery (SICS)

Group Type ACTIVE_COMPARATOR

Small incision cataract surgery

Intervention Type PROCEDURE

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

Interventions

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Phacoemulsification cataract extraction surgery

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

Intervention Type PROCEDURE

Small incision cataract surgery

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RM-08-002

Identifier Type: -

Identifier Source: org_study_id