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Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00762021
First Posted: September 30, 2008
Last Update Posted: December 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

Condition Intervention
Cataract Device: SN60AT Device: SN60WF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Posterior Capsule Opacification (PCO) [ Time Frame: 2 years after surgery ]
    Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.

  • 100% LogMAR Best Corrected Visual Acuity (BCVA) [ Time Frame: 24 months after surgery ]

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.

    VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.


  • 9% LogMAR Best Corrected Visual Acuity (BCVA) [ Time Frame: 24 months after surgery ]

    Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.

    VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.



Enrollment: 104
Study Start Date: December 2006
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT
Device: SN60AT
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
Active Comparator: SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF
Device: SN60WF
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with bilateral senile cataracts
  • Age > 50 years
  • Fit for hospital follow ups
  • Pupils dilating > 6mm preoperatively
  • Eyes expected to see 6/12 or better postoperatively

Exclusion Criteria:

  • Diabetes
  • On treatment for glaucoma
  • Other ocular pathology
  • Previous ocular surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762021


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

Responsible Party: Diane Houtman, Associate Director, Surgical IOL, Clinical Science
ClinicalTrials.gov Identifier: NCT00762021     History of Changes
Other Study ID Numbers: P-06-26
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: September 30, 2010
Results First Posted: December 22, 2010
Last Update Posted: December 22, 2010
Last Verified: November 2010

Keywords provided by Alcon Research:
cataract

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases


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