NCT00821223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 19, 2010

Status Verified

May 1, 2010

Enrollment Period

1.2 years

First QC Date

January 9, 2009

Last Update Submit

May 18, 2010

Conditions

Visual OutcomesQuality of Life

Keywords

phacoemulsificationmanual small incision cataract surgeryvisual acuitycontrast sensitivityquality of vision

Outcome Measures

Primary Outcomes (1)

  • immediate unaided and aided visual acuity

    immediate and mid term (12 months)

Secondary Outcomes (3)

  • 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

Study Arms (2)

manual small incision cataract surgery

ACTIVE COMPARATOR

surgical intervention by small incision cataract surgery

Procedure: manual small incision surgery

phacoemulsification

OTHER

surgical intervention by phacoemulsification

Procedure: phacoemulsification and SICSProcedure: phacoemulsification

Interventions

phacoemulsification and SICSPROCEDURE

SICS with rigid IOL implantation Phaco with foldable IOL implantation

Also known as: ECCE, Manual SICS
phacoemulsification
manual small incision surgeryPROCEDURE
Also known as: exrtracapsular cataract surgery
manual small incision cataract surgery
phacoemulsificationPROCEDURE

cataract surgery

Also known as: extracapsualr cataract surgery
phacoemulsification

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. K. Red Cross Eye Hospital,

Dholka, Gujarat, India

Location

Related 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. doi: 10.1016/j.ophtha.2006.08.057. Epub 2007 Feb 12.

    PMID: 17296230RESULT

  • 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.

    PMID: 17188040RESULT

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Alpesh R Shah, Dr

    Iladevi Cataract and IOL Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 19, 2010

Record last verified: 2010-05

Locations

IN(1)