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

Aphakia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098367
• Other study ID #: ILI875-P001
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: July 22, 2021

Study information

• Verified date: May 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 22, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• VIVITY
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
• SYMFONY
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
• AT LARA
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

Procedure:
• Cataract surgery
Cataract removal by routine small incision surgery

Locations

Country	Name	City	State
Australia	Alcon Investigator 8047	Charlestown	New South Wales
Australia	Alcon Investigator 8052	Eastwood	South Australia
Australia	Alcon Investigator 8010	Essendon	Victoria
Australia	Alcon Investigator 7813	Footscray	Victoria
Australia	Alcon Investigator 7130	Hobart	Tasmania
Australia	Alcon Investigator 1702	Mornington	Victoria
Australia	Alcon Investigator 8051	Murdoch	Western Australia
Australia	Alcon Investigator 6667	Sydney	New South Wales
Australia	Alcon Investigator 7678	Sydney	New South Wales
New Zealand	Alcon Investigator 8050	Auckland
New Zealand	Alcon Investigator 8056	Auckland
New Zealand	Alcon Investigator 3656	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Month 3 postoperative (Day 120-180 from second eye surgery)
Secondary	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.	Month 3 postoperative (Day 120-180 from second eye surgery)