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Trial record 36 of 1151 for:    cataract

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

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ClinicalTrials.gov Identifier: NCT00762606
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : July 8, 2011
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Cataract Procedure: Phacoemulsification cataract extraction surgery Procedure: Small incision cataract surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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.
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762606


Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00762606     History of Changes
Other Study ID Numbers: RM-08-002
First Posted: September 30, 2008    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: October 31, 2012
Last Verified: August 2011

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases