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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SN60AT
SN60WF
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SN60AT

SN60WF

Arm Description

Implantation with the AcrySof Intraocular Lens Model SN60AT

Implantation with the AcrySof Intraocular Lens Model SN60WF

Outcomes

Primary Outcome Measures

Posterior Capsule Opacification (PCO)
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)
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)
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
November 24, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00762021
Brief Title
Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SN60AT
Arm Type
Experimental
Arm Description
Implantation with the AcrySof Intraocular Lens Model SN60AT
Arm Title
SN60WF
Arm Type
Active Comparator
Arm Description
Implantation with the AcrySof Intraocular Lens Model SN60WF
Intervention Type
Device
Intervention Name(s)
SN60AT
Intervention Description
Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
Intervention Type
Device
Intervention Name(s)
SN60WF
Intervention Description
Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.
Primary Outcome Measure Information:
Title
Posterior Capsule Opacification (PCO)
Description
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.
Time Frame
2 years after surgery
Title
100% LogMAR Best Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
24 months after surgery
Title
9% LogMAR Best Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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