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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762021
First received: September 26, 2008
Last updated: November 24, 2010
Last verified: November 2010
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Diane Houtman, Associate Director, Surgical IOL, Clinical Science
ClinicalTrials.gov Identifier: NCT00762021     History of Changes
Other Study ID Numbers: P-06-26
Study First Received: September 26, 2008
Results First Received: September 30, 2010
Last Updated: November 24, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
cataract

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

ClinicalTrials.gov processed this record on August 01, 2014