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

Alcon

Status: Completed

Conditions: Cataract

Treatments: Procedure: Small incision cataract surgery; Procedure: Phacoemulsification cataract extraction surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762606

RM-08-002

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Phaco

Active Comparator group

Description:

Cataract extraction surgery utilizing Phacoemulsification

Treatment:

Procedure: Phacoemulsification cataract extraction surgery

SICS

Active Comparator group

Description:

Small incision cataract surgery (SICS)

Treatment:

Procedure: Small incision cataract surgery