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Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Primary Purpose

Visual Outcomes, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
phacoemulsification and SICS
manual small incision surgery
phacoemulsification
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Outcomes focused on measuring phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • S. K. Red Cross Eye Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

manual small incision cataract surgery

phacoemulsification

Arm Description

surgical intervention by small incision cataract surgery

surgical intervention by phacoemulsification

Outcomes

Primary Outcome Measures

immediate unaided and aided visual acuity

Secondary Outcome Measures

Assessment of unaided and aided low contrast sensitivity
Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
To assess improvement in quality of life

Full Information

First Posted
January 9, 2009
Last Updated
May 18, 2010
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00821223
Brief Title
Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
Official Title
Comparison of Phacoemulsification Versus Manual Small Incision Cataract Surgery (SICS) : A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Outcomes, Quality of Life
Keywords
phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual small incision cataract surgery
Arm Type
Active Comparator
Arm Description
surgical intervention by small incision cataract surgery
Arm Title
phacoemulsification
Arm Type
Other
Arm Description
surgical intervention by phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification and SICS
Other Intervention Name(s)
ECCE, Manual SICS
Intervention Description
SICS with rigid IOL implantation Phaco with foldable IOL implantation
Intervention Type
Procedure
Intervention Name(s)
manual small incision surgery
Other Intervention Name(s)
exrtracapsular cataract surgery
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Other Intervention Name(s)
extracapsualr cataract surgery
Intervention Description
cataract surgery
Primary Outcome Measure Information:
Title
immediate unaided and aided visual acuity
Time Frame
immediate and mid term (12 months)
Secondary Outcome Measure Information:
Title
Assessment of unaided and aided low contrast sensitivity
Time Frame
3 and 12 months
Title
Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
Time Frame
day 1, 1 week
Title
To assess improvement in quality of life
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpesh R Shah, Dr
Organizational Affiliation
Iladevi Cataract and IOL Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
S. K. Red Cross Eye Hospital,
City
Dholka
State/Province
Gujarat
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17296230
Citation
Gogate P, Deshpande M, Nirmalan PK. Why do phacoemulsification? Manual small-incision cataract surgery is almost as effective, but less expensive. Ophthalmology. 2007 May;114(5):965-8. doi: 10.1016/j.ophtha.2006.08.057. Epub 2007 Feb 12.
Results Reference
result
PubMed Identifier
17188040
Citation
Ruit S, Tabin G, Chang D, Bajracharya L, Kline DC, Richheimer W, Shrestha M, Paudyal G. A prospective randomized clinical trial of phacoemulsification vs manual sutureless small-incision extracapsular cataract surgery in Nepal. Am J Ophthalmol. 2007 Jan;143(1):32-38. doi: 10.1016/j.ajo.2006.07.023. Epub 2006 Sep 5.
Results Reference
result

Learn more about this trial

Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

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