Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Visual Outcomes, Quality of Life

Intervention / Treatment
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* Procedure: phacoemulsification and SICS
* Procedure: manual small incision surgery
* Procedure: phacoemulsification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: manual small incision cataract surgery<br>surgical intervention by small incision cataract surgery | Procedure: manual small incision surgery<br> <br> * Other names: exrtracapsular cataract surgery;|
| Other: phacoemulsification<br>surgical intervention by phacoemulsification | Procedure: phacoemulsification and SICS<br>* SICS with rigid IOL implantation Phaco with foldable IOL implantation<br>* Other names: Manual SICS;Procedure: phacoemulsification<br>* cataract surgery<br>* Other names: extracapsualr cataract surgery;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision