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

October 26, 2012 updated by: Alcon Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phaco
Cataract extraction surgery utilizing Phacoemulsification
Procedure: Phacoemulsification cataract extraction surgery
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
Active Comparator: SICS
Small incision cataract surgery (SICS)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posterior Capsule Opacification Evaluation
Time Frame: 12 months after surgery
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
Time Frame: 3 months after surgery
Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-08-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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