A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
1 other identifier
interventional
31
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
Shorter than P25 for not_applicable
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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 8, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
April 20, 2017
CompletedJuly 2, 2018
March 1, 2017
7 months
December 8, 2010
January 13, 2017
May 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Binocular Defocus VA at Month 3
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Month 3 from second eye implantation
Secondary Outcomes (5)
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Month 3 from second eye implantation
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Month 3 from second eye implantation
Mean Refractive Spherical Equivalent at Month 3
Month 3 from second eye implantation
Mean Radner Reading Speed
Month 3 from second eye implantation
Patient Reported Outcomes at Month 3
Month 3 from second eye implantation
Study Arms (2)
ReSTOR +3
EXPERIMENTALAcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
Acri.LISA
ACTIVE COMPARATORAcri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Interventions
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Eligibility Criteria
You may qualify if:
- Sign informed consent;
- Able to attend postoperative examinations per protocol schedule;
- Diagnosed with bilateral cataracts;
- Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- Preoperative astigmatism ≤ 2.5 diopter;
- Good ocular health, with the exception of cataracts;
- Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- Able to undergo second eye surgery within one month of the first eye surgery;
You may not qualify if:
- Previous corneal surgery;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Any ocular disease and/or condition that may compromise study results;
- Pregnant or planning pregnancy during course of study;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Diabetic retinopathy;
- Macular degeneration;
- History of retinal detachment;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brand Lead, Surgical, Global Medical Affairs
- Organization
- Alcon Research, Ltd.
Study Officials
- STUDY DIRECTOR
Brand Lead, Surgical, Global Medical Affairs
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2010
First Posted
December 9, 2010
Study Start
November 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 2, 2018
Results First Posted
April 20, 2017
Record last verified: 2017-03