REVIVE: Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control
Study Details
Study Description
Brief Summary
Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Study Group: Vivity ACRYSOF IQ IOL Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens |
Device: Study Group
Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
|
Control Group: ACRYSOF IQ IOL Control Group: Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens |
Device: Control Group
Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens
|
Outcome Measures
Primary Outcome Measures
- Best Corrected Distance Visual Acuity (BCDVAA) [After 1 year post-op]
Best correct distance visual acuity
- Best Corrected Intermediate Visual Acuity (BCIVA) [After 1 year post-op]
Best correct intermediate visual acuity
- Defocus Curve [After 1 year post-op]
Secondary Outcome Measures
- Uncorrected Distance Visual Acuity (UCDVA) [After 1 year post-op]
Uncorrected Distance Visual Acuity
- UCNVA [After 1 year post-op]
Uncorrected Near Visual Acuity
- Dyphotopsia rate [After 1 year post-op]
Demonstrated by responses on questionnaire
- Post-operative IOLSAT [After 1 year post-op]
Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome
- (Post-operative QUVID) [After 1 year post-op]
Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
Must have participated in the FDA study at one of the included sites
Exclusion Criteria:
None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
Sponsors and Collaborators
- John Berdahl, MD
- Alcon Research
- Cathleen McCabe, MD
- Harvey Reiser, MD
- T. Hunter Newsom, MD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The REVIVE Study