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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762606
• Other study ID #: RM-08-002
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: October 26, 2012
• Start date: September 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Phacoemulsification cataract extraction surgery
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)
• 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).

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior Capsule Opacification Evaluation	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.	12 months after surgery	No
Secondary	Corneal Astigmatism	Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.	3 months after surgery	No