Clinical Trials Directory

Trials / Completed

CompletedNCT00821223

Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
420 (actual)
Sponsor
Iladevi Cataract and IOL Research Center · Academic / Other
Sex
All
Age
50 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Hypothesis : Phacoemulsification is superior to SICS with regards to: * Immediate unaided high and low contrast visual performance * Its impact on quality of life.

Detailed 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

Conditions

Interventions

TypeNameDescription
PROCEDUREphacoemulsification and SICSSICS with rigid IOL implantation Phaco with foldable IOL implantation
PROCEDUREmanual small incision surgery
PROCEDUREphacoemulsificationcataract surgery

Timeline

Start date
2009-02-01
Primary completion
2010-05-01
Completion
2010-05-01
First posted
2009-01-13
Last updated
2010-05-19

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT00821223. Inclusion in this directory is not an endorsement.