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OpenTrials
Completed

NCT Number: NCT00821223

Outcome Following Phacoemulsification Versus Small Incision Cataract Surgery (SICS)

Hypothesis :

Phacoemulsification is superior to SICS with regards to:

* Immediate unaided high and low contrast visual performance * Its impact on quality of life.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. K. Red Cross Eye Hospital,

Dholka, Gujarat, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

phacoemulsification and SICS

Procedure

SICS with rigid IOL implantation Phaco with foldable IOL implantation

Other names: ECCE, Manual SICS

manual small incision surgery

Procedure

Other names: exrtracapsular cataract surgery

phacoemulsification

Procedure

cataract surgery

Other names: extracapsualr cataract surgery

Primary outcomes

  1. immediate unaided and aided visual acuity

    Time frame: immediate and mid term (12 months)

Secondary outcomes

  1. Assessment of unaided and aided low contrast sensitivity

    Time frame: 3 and 12 months

  2. Intra-operative complications immediate post-operative day corneal edema anterior chamber inflammation

    Time frame: day 1, 1 week

  3. To assess improvement in quality of life

    Time frame: 3 and 12 months

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2009
Registry last updated
May 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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