Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens
1 other identifier
interventional
104
1 country
1
Brief Summary
To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
December 22, 2010
CompletedDecember 22, 2010
November 1, 2010
2.7 years
September 26, 2008
September 30, 2010
November 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
2 years after surgery
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.
24 months after surgery
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.
24 months after surgery
Study Arms (2)
SN60AT
EXPERIMENTALImplantation with the AcrySof Intraocular Lens Model SN60AT
SN60WF
ACTIVE COMPARATORImplantation with the AcrySof Intraocular Lens Model SN60WF
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diabetes
- On treatment for glaucoma
- Other ocular pathology
- Previous ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
December 1, 2006
Primary Completion
August 1, 2009
Last Updated
December 22, 2010
Results First Posted
December 22, 2010
Record last verified: 2010-11