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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758745
First received: September 23, 2008
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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).


Condition Intervention
Cataract
 Device: Model SN60WF
Device: Model MA60AC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Posterior Capsule Opacification (PCO) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 81
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Model SN60WF
Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
 Device: Model SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
Active Comparator: Model MA60AC
Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
 Device: Model MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758745

Locations
United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Diane Houtman, Alcon
ClinicalTrials.gov Identifier: NCT00758745     History of Changes
Other Study ID Numbers: P-06-03
Study First Received: September 23, 2008
Results First Received: July 1, 2011
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Cataract
Patients
bilateral
 age related
undergoing
phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013