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

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

VIVITY

SYMFONY

AT LARA

Cataract surgery

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Cataracts, Extracapsular cataract extraction, IOL, Extended depth of focus, Visual disturbances, Presbyopia, Intraocular lens

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

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.
Other protocol-specified exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

VIVITY

SYMFONY

AT LARA

Arm Description

VIVITY IOL implanted in the eye during cataract surgery

SYMFONY IOL implanted in the eye during cataract surgery

AT LARA implanted in the eye during cataract surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare 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.

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

A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts 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.

Full Information

NCT ID

NCT04098367

First Posted

September 19, 2019

Last Updated

May 2, 2022

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT04098367

Brief Title

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

Official Title

A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 18, 2019 (Actual)

Primary Completion Date

May 3, 2021 (Actual)

Study Completion Date

July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphakia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIVITY

Arm Type

Experimental

Arm Description

VIVITY IOL implanted in the eye during cataract surgery

Arm Title

SYMFONY

Arm Type

Active Comparator

Arm Description

SYMFONY IOL implanted in the eye during cataract surgery

Arm Title

AT LARA

Arm Type

Active Comparator

Arm Description

AT LARA implanted in the eye during cataract surgery

Intervention Type

Device

Intervention Name(s)

VIVITY

Other Intervention Name(s)

AcrySof™ IQ Vivity™ Extended Vision IOL Model DFT015

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SYMFONY

Other Intervention Name(s)

TECNIS Symfony® Extended Range of Vision IOL Model ZXR00

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

AT LARA

Other Intervention Name(s)

AT LARA® extended depth of focus IOL Model 829MP

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Cataract surgery

Intervention Description

Cataract removal by routine small incision surgery

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare 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.

Time Frame

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

Title

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

Description

A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts 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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 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. Other protocol-specified exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Lead, Surgical

Organizational Affiliation

Alcon Research, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigator 8047

City

Charlestown

State/Province

New South Wales

ZIP/Postal Code

2290

Country

Australia

Facility Name

Alcon Investigator 6667

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2067

Country

Australia

Facility Name

Alcon Investigator 7678

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2150

Country

Australia

Facility Name

Alcon Investigator 8052

City

Eastwood

State/Province

South Australia

ZIP/Postal Code

5063

Country

Australia

Facility Name

Alcon Investigator 7130

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Alcon Investigator 8010

City

Essendon

State/Province

Victoria

ZIP/Postal Code

3040

Country

Australia

Facility Name

Alcon Investigator 7813

City

Footscray

State/Province

Victoria

ZIP/Postal Code

3011

Country

Australia

Facility Name

Alcon Investigator 1702

City

Mornington

State/Province

Victoria

ZIP/Postal Code

3931

Country

Australia

Facility Name

Alcon Investigator 8051

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Alcon Investigator 8056

City

Auckland

ZIP/Postal Code

1050

Country

New Zealand

Facility Name

Alcon Investigator 8050

City

Auckland

Country

New Zealand

Facility Name

Alcon Investigator 3656

City

Wellington

ZIP/Postal Code

6011

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

No

Aphakia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial