Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control

Cataract Clinical Trial

— REVIVE  

Official title:

Long Term Outcomes of Vivity IOL Versus Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561570
• Other study ID #: The REVIVE Study
• Status: Completed
• Start date: September 17, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: July 2023
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Must have participated in the FDA study at one of the included sites

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Vivity ACRYSOF IQ IOL Group
Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
• ACRYSOF IQ IOL Control Group
Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (5)

Lead Sponsor	Collaborator
John Berdahl, MD	Alcon Research, Eye Care Specialists, NewsomeEye, The Eye Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Distance Visual Acuity (BCDVAA)	Best correct distance visual acuity	After 1 year post-op
Primary	Best Corrected Intermediate Visual Acuity (BCIVA)	Best correct intermediate visual acuity	After 1 year post-op
Primary	Defocus Curve		After 1 year post-op
Secondary	Uncorrected Distance Visual Acuity (UCDVA)	Uncorrected Distance Visual Acuity	After 1 year post-op
Secondary	UCNVA	Uncorrected Near Visual Acuity	After 1 year post-op
Secondary	Dyphotopsia rate	Demonstrated by responses on questionnaire	After 1 year post-op
Secondary	Post-operative IOLSAT	Questionnaire about satisfaction with your vision after surgery. 0-4 scale with 4 being the worse outcome	After 1 year post-op
Secondary	(Post-operative QUVID)	Questionnaire about the quality of your vision after surgery.0-4 scale with 4 being the worse outcome	After 1 year post-op