Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

May 18, 2010 updated by: Iladevi Cataract and IOL Research Center

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

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Dholka, Gujarat, India
        • S. K. Red Cross Eye Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: manual small incision cataract surgery
surgical intervention by small incision cataract surgery
Procedure: manual small incision surgery
Other Names:
  • exrtracapsular cataract surgery
Other: phacoemulsification
surgical intervention by phacoemulsification
Procedure: phacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
Other Names:
  • ECCE
  • Manual SICS
Procedure: phacoemulsification
cataract surgery
Other Names:
  • extracapsualr cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
immediate unaided and aided visual acuity
Time Frame: immediate and mid term (12 months)
immediate and mid term (12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of unaided and aided low contrast sensitivity
Time Frame: 3 and 12 months
3 and 12 months
Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
Time Frame: day 1, 1 week
day 1, 1 week
To assess improvement in quality of life
Time Frame: 3 and 12 months
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iladevi Cataract and IOL Research Center

Investigators

  • Principal Investigator: Alpesh R Shah, Dr, Iladevi Cataract and IOL Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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