Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821223
• Other study ID #: 009
• Status: Completed
• Phase: N/A
• First received: January 9, 2009
• Last updated: May 18, 2010
• Start date: February 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

• Immediate unaided high and low contrast visual performance

• Its impact on quality of life.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Quality of Life
• Surgical Wound
• Visual Outcomes

Intervention

Procedure:
• phacoemulsification and SICS
SICS with rigid IOL implantation Phaco with foldable IOL implantation
• manual small incision surgery

• phacoemulsification
cataract surgery

Locations

Country	Name	City	State
India	S. K. Red Cross Eye Hospital,	Dholka	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

References & Publications (2)

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. Epub 2007 Feb 12. — View 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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immediate unaided and aided visual acuity		immediate and mid term (12 months)
Secondary	Assessment of unaided and aided low contrast sensitivity		3 and 12 months
Secondary	Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation		day 1, 1 week
Secondary	To assess improvement in quality of life		3 and 12 months