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

This study is currently recruiting participants.

Verified by Alcon Research, September 2008

First Received: September 26, 2008 Last Updated: July 1, 2009 History of Changes

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

Purpose

To compare the health economic parameter and clinical outcome of Phaco 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:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phaco vs. SICS in Chinese and Indian Patients With Senile Cataract.

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

Further study details as provided by Alcon Research:

Primary Outcome Measures:

PCO evaluation; corneal Astigmatism [ Time Frame: PCR evalutaion: before surgery,6M and 12M after surgery; Corneal astigmatism: before surgery,3M after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Contrast sensitivity; IOP [ Time Frame: Contrast sensitivity:3M,6M after surgery; IOP:before surgery,1D and 2W after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	280
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Phacoemulsification cataract extraction surgery	Procedure: Phacoemulsification cataract extraction surgery Surgical removal of cataract
2: Active Comparator Small incision cataract surgery	Procedure: Small incision cataract surgery Surgical removal of cataract

Eligibility

Criteria

Inclusion Criteria:

Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA posterior chamber 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

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

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

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research Ltd. ( Benny Li, Regional Scientific Clinical Affairs Manager )
Study ID Numbers:	RM-08-002
Study First Received:	September 26, 2008
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00762606 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Alcon Research:

Cataract

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on February 08, 2010