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Completed

NCT Number: NCT00762606

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification cataract extraction surgery

Procedure

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

Small incision cataract surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2008
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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