Presbyopia-Correcting Intraocular Lenses (IOLs)
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs
1 other identifier
interventional
132
1 country
1
Brief Summary
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 19, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedResults Posted
Study results publicly available
August 9, 2011
CompletedAugust 9, 2011
July 1, 2011
1.6 years
August 19, 2009
July 13, 2011
July 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity
Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
6 Months after surgery
Study Arms (3)
ReSTOR +3
EXPERIMENTALBilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
Crystalens HD
ACTIVE COMPARATORBilateral implantation of Crystalens HD Intraocular Lens (IOL)
Crystalens AO
ACTIVE COMPARATORBilateral implantation of Crystalens AO Intraocular Lens (IOL)
Interventions
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
Eligibility Criteria
You may qualify if:
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
You may not qualify if:
- \> 1 Diopter preoperative astigmatism by Keratometry readings
- pre-existing conditions that could skew the results
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
- Director of 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
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 19, 2009
First Posted
August 21, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2011
Last Updated
August 9, 2011
Results First Posted
August 9, 2011
Record last verified: 2011-07