Clinical trial NCT00821223: 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
Overall status: COMPLETED
Phase: NA
Conditions: Visual Outcomes
Quality of Life
Keywords: phacoemulsification
manual small incision cataract surgery
visual acuity
contrast sensitivity
quality of vision
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 420
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: immediate unaided and aided visual acuity
timeFrame: immediate and mid term (12 months)
Secondary outcomes:
measure: Assessment of unaided and aided low contrast sensitivity
timeFrame: 3 and 12 months
measure: Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation
timeFrame: day 1, 1 week
measure: To assess improvement in quality of life
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Dholka
country: India
facility: S. K. Red Cross Eye Hospital,
state: Gujarat
Study officials:
affiliation: Iladevi Cataract and IOL Research Center
name: Alpesh R Shah, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.