Quality of Life, Visual Outcomes
Conditions
Keywords
phacoemulsification, manual small incision cataract surgery, visual acuity, contrast sensitivity, quality of vision
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
Interventions
PROCEDUREphacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
PROCEDUREmanual small incision surgery
PROCEDUREphacoemulsification
cataract surgery
Sponsors
Iladevi Cataract and IOL Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immediate unaided and aided visual acuity | immediate and mid term (12 months) |
Secondary
| Measure | 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 |
Countries
India
Outcome results
None listed