Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
NCT ID: NCT00821223
Last Updated: 2010-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2009-02-28
2010-05-31
Brief Summary
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Phacoemulsification is superior to SICS with regards to:
* Immediate unaided high and low contrast visual performance
* Its impact on quality of life.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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manual small incision cataract surgery
surgical intervention by small incision cataract surgery
manual small incision surgery
phacoemulsification
surgical intervention by phacoemulsification
phacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
phacoemulsification
cataract surgery
Interventions
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phacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
manual small incision surgery
phacoemulsification
cataract surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
50 Years
65 Years
ALL
No
Sponsors
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Iladevi Cataract and IOL Research Center
OTHER
Responsible Party
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Iladevi Cataract and IOL Research Center, Ahmedabad, India
Principal Investigators
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Alpesh R Shah, Dr
Role: PRINCIPAL_INVESTIGATOR
Iladevi Cataract and IOL Research Center
Locations
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S. K. Red Cross Eye Hospital,
Dholka, Gujarat, India
Countries
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References
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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.
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.
Other Identifiers
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009
Identifier Type: -
Identifier Source: org_study_id
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