Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Visual Outcomes; Quality of Life

Treatments: Procedure: phacoemulsification and SICS; Procedure: manual small incision surgery; Procedure: phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT00821223

009

Details and patient eligibility

About

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

• Immediate unaided high and low contrast visual performance
• Its impact on quality of life.

Full description

Phacoemulsification procedure

• Infiniti Vision System with Software 2.03 or higher, OZil handpiece (HP)
• Anaesthesia: topical
• Incision: temporal clear corneal 2.2 mm single plane
• CCC and hydrodissection, sculpting and division using step by step chop in situ and lateral separation, I/A.
• Single-piece AcrySof IOL (SN60WF) in the bag

SICS procedure

• Anaesthesia: peribulbar
• Incision: superior scleral tunnel 6.5 to 7 mm
• CCC and hydrodissection
• Nuclear expression: blumenthal technique using anterior chamber maintainer, manual cortical clean-up
• Single-piece PMMA (MZ60BD) in the bag

Enrollment: 420 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prospective subjects should be diagnosed with senile cataract. Subject must require extraction of cataract in one eye followed by implantation of an AcrySof (SN60WF) or PMMA (MZ60BD) posterior chamber intraocular lens.
• Pupil dilation equal or greater to 7 mm after mydriasis.
• Patients undergoing cataract surgery for the first eye.
• Visual prognosis equal or greater to 6/12.

Exclusion criteria

• Patients with history of ocular pathology, glaucoma, uveitis, high myopia, PEX, or corneal pathology.
• Patients with traumatic, subluxated and posterior polar cataract.
• Patients who had previously ocular surgery in the past 6 months prior to the screening visit.
• Patients with diabetic retinopathy.
• Patients who are not suitable for follow-up visits.
• Patients with Fuchs' Dystrophy, Macular Degeneration, Ocular Surface Disease that will interfere with normal recovery.
• Any patients with significant intra-operative complications will be removed from the overall analysis of the results. All patient data should still be recorded, even if from the "excluded" patient group.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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420 participants in 2 patient groups

manual small incision cataract surgery

Active Comparator group

Description:

surgical intervention by small incision cataract surgery

Treatment:

Procedure: manual small incision surgery

phacoemulsification

Other group

Description:

surgical intervention by phacoemulsification

Treatment:

Procedure: phacoemulsification

Procedure: phacoemulsification and SICS