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Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT00821223
First received: January 9, 2009
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
  Purpose

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

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

Condition Intervention
Visual Outcomes
Quality of Life
 Procedure: phacoemulsification and SICS
Procedure: manual small incision surgery
Procedure: phacoemulsification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • immediate unaided and aided visual acuity [ Time Frame: immediate and mid term (12 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of unaided and aided low contrast sensitivity [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation [ Time Frame: day 1, 1 week ] [ Designated as safety issue: No ]
  • To assess improvement in quality of life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: manual small incision cataract surgery
surgical intervention by small incision cataract surgery
 Procedure: manual small incision surgery
Other Name: exrtracapsular cataract surgery
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 Name: extracapsualr cataract surgery

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
  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821223

Locations
India
S. K. Red Cross Eye Hospital,
Dholka, Gujarat, India
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Alpesh R Shah, Dr Iladevi Cataract and IOL Research Center
  More Information

Publications:

Responsible Party: Dr. Alpesh Shah, Iladevi Cataract and IOL Research Center, Ahmedabad, India
ClinicalTrials.gov Identifier: NCT00821223     History of Changes
Other Study ID Numbers: 009
Study First Received: January 9, 2009
Last Updated: May 18, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
phacoemulsification
manual small incision cataract surgery
visual acuity
contrast sensitivity
quality of vision

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013