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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762606
First received: September 26, 2008
Last updated: October 26, 2012
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Cataract
 Procedure: Phacoemulsification cataract extraction surgery
Procedure: Small incision cataract surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Posterior Capsule Opacification Evaluation [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    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:
  • Corneal Astigmatism [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.


Enrollment: 106
Study Start Date: September 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762606

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00762606     History of Changes
Other Study ID Numbers: RM-08-002
Study First Received: September 26, 2008
Results First Received: June 7, 2011
Last Updated: October 26, 2012
Health Authority: China: Ethics Committee

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013