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OpenTrials
Completed

NCT Number: NCT00758745

Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).

Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Study Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 50 years
  • Clear cornea
  • Pupil mydriasis ≥ 7mm
  • In the bag Intraocular Lens (IOL)

Exclusion criteria

  • Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia
  • Previously operated eye
  • Proliferative diabetic retinopathy
  • Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis

Treatment and study plan

Model SN60WF

Device

Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.

Model MA60AC

Device

Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.

Primary outcomes

  1. Posterior Capsule Opacification (PCO)

    Time frame: Up to 3 years

    Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Aug 19, 2014

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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