Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

NCT04098367 | Completed Results FDA Device

• 1 other identifier: ILI875-P001
• Study Type: interventional
• Target: 222
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.

Conditions

Aphakia

Keywords

Cataracts; Extracapsular cataract extraction; IOL; Extended depth of focus; Visual disturbances; Presbyopia; Intraocular lens

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)

  QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.

  Month 3 postoperative (Day 120-180 from second eye surgery)

Secondary Outcomes (2)

• Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)

  Month 3 postoperative (Day 120-180 from second eye surgery)

• Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)

  Month 3 postoperative (Day 120-180 from second eye surgery)

Study Arms (3)

VIVITY

EXPERIMENTAL

VIVITY IOL implanted in the eye during cataract surgery

Device: VIVITY; Procedure: Cataract surgery

SYMFONY

ACTIVE COMPARATOR

SYMFONY IOL implanted in the eye during cataract surgery

Device: SYMFONY; Procedure: Cataract surgery

AT LARA

ACTIVE COMPARATOR

AT LARA implanted in the eye during cataract surgery

Device: AT LARA; Procedure: Cataract surgery

Interventions

VIVITY DEVICE

Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction

Also known as: AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015

VIVITY

SYMFONY DEVICE

Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed

Also known as: TECNIS Symfony® Extended Range of Vision IOL Model ZXR00

SYMFONY

AT LARA DEVICE

Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction

Also known as: AT LARA® extended depth of focus IOL Model 829MP

AT LARA

Cataract surgery PROCEDURE

Cataract removal by routine small incision surgery

AT LARA; SYMFONY; VIVITY

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cataract removal in both eyes.
• Willing and able to complete all required postoperative visits.
• Able to understand, read and write English and willing to sign an approved statement of informed consent.

You may not qualify if:

• Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding.
• Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol.
• Ocular trauma or ocular surface disease that would affect study measurements.
• Patients who desire monovision correction.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (12)

Alcon Investigator 8047

Charlestown, New South Wales, 2290, Australia

Location

Alcon Investigator 6667

Sydney, New South Wales, 2067, Australia

Location

Alcon Investigator 7678

Sydney, New South Wales, 2150, Australia

Location

Alcon Investigator 8052

Eastwood, South Australia, 5063, Australia

Location

Alcon Investigator 7130

Hobart, Tasmania, 7000, Australia

Location

Alcon Investigator 8010

Essendon, Victoria, 3040, Australia

Location

Alcon Investigator 7813

Footscray, Victoria, 3011, Australia

Location

Alcon Investigator 1702

Mornington, Victoria, 3931, Australia

Location

Alcon Investigator 8051

Murdoch, Western Australia, 6150, Australia

Location

Alcon Investigator 8056

Auckland, 1050, New Zealand

Location

Alcon Investigator 8050

Auckland, New Zealand

Location

Alcon Investigator 3656

Wellington, 6011, New Zealand

Location

MeSH Terms

Conditions

Aphakia; Cataract; Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Sr. CDMA Project Lead, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: November 18, 2019
• Primary Completion: May 3, 2021
• Study Completion: July 22, 2021
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9); NZ (3)