Status:
COMPLETED
Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)
Lead Sponsor:
Iladevi Cataract and IOL Research Center
Conditions:
Visual Outcomes
Quality of Life
Eligibility:
All Genders
50-65 years
Phase:
NA
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 hydrod...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00821223
Start Date
February 1 2009
End Date
May 1 2010
Last Update
May 19 2010
Active Locations (1)
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1
S. K. Red Cross Eye Hospital,
Dholka, Gujarat, India