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

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ClinicalTrials.gov Identifier: NCT00762021
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 22, 2010
Last Update Posted : December 22, 2010
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

Condition or disease Intervention/treatment Phase
Cataract Device: SN60AT Device: SN60WF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2006
Actual Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
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Responsible Party: Diane Houtman, Associate Director, Surgical IOL, Clinical Science
ClinicalTrials.gov Identifier: NCT00762021    
Other Study ID Numbers: P-06-26
First Posted: September 30, 2008    Key Record Dates
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:
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Cataract
Lens Diseases
Eye Diseases