Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study - Full Text View

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00762606

Purpose

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

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

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

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:

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:	Benny Li, Regional Scientific Clinical Affairs Manager, Alcon Research Ltd.
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:	August 9, 2011
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 February 09, 2012