Trial Outcomes & Findings for Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses (NCT NCT04591054)

Last Updated: 2023-08-21

Results Overview

Mean logMAR best-distance corrected visual acuity at intermediate (66 cm) tested in binocular photopic conditions at 3 months.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

3 months

Results posted on

2023-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Extended Vision IOL Vivity Extended Vision IOL: Vivity IOL implantation following cataract extraction	Neutral Aspheric Monofocal IOL enVista \[MX60E\] Neutral Aspheric Monofocal IOL: enVista IOL implantation following cataract extraction
Overall Study STARTED	28	28
Overall Study COMPLETED	24	27
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extended Vision IOL n=24 Participants Vivity Extended Vision IOL: Vivity IOL implantation following cataract extraction	Neutral Aspheric Monofocal IOL n=27 Participants enVista \[MX60E\] Neutral Aspheric Monofocal IOL: enVista IOL implantation following cataract extraction	Total n=51 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 6.3 • n=93 Participants	66 years STANDARD_DEVIATION 8.1 • n=4 Participants	66.5 years STANDARD_DEVIATION 7.24 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=93 Participants	24 Participants n=4 Participants	46 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	21 Participants n=93 Participants	25 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	24 participants n=93 Participants	27 participants n=4 Participants	51 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

Mean logMAR best-distance corrected visual acuity at intermediate (66 cm) tested in binocular photopic conditions at 3 months.

Outcome measures

Outcome measures
Measure	Extended Vision IOL n=24 Participants Vivity Extended Vision IOL: Vivity IOL implantation following cataract extraction	Neutral Aspheric Monofocal IOL n=27 Participants enVista \[MX60E\] Neutral Aspheric Monofocal IOL: enVista IOL implantation following cataract extraction
Binocular Intermediate Vision	-0.02 logMAR Standard Deviation 0.13	0.19 logMAR Standard Deviation 0.14

Adverse Events

Extended Vision IOL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Neutral Aspheric Monofocal IOL

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Extended Vision IOL n=24 participants at risk Vivity Extended Vision IOL: Vivity IOL implantation following cataract extraction	Neutral Aspheric Monofocal IOL n=27 participants at risk enVista \[MX60E\] Neutral Aspheric Monofocal IOL: enVista IOL implantation following cataract extraction
Eye disorders Cystoid Macular Edema	4.2% 1/24 • Number of events 1 • 3 months	3.7% 1/27 • Number of events 1 • 3 months
Eye disorders Corneal Abrasion	0.00% 0/24 • 3 months	7.4% 2/27 • Number of events 2 • 3 months
Eye disorders increased intraocular pressure	4.2% 1/24 • Number of events 1 • 3 months	0.00% 0/27 • 3 months
Eye disorders Breakthrough inflammation	4.2% 1/24 • Number of events 1 • 3 months	3.7% 1/27 • Number of events 1 • 3 months
Eye disorders Prolonged corneal edema	0.00% 0/24 • 3 months	3.7% 1/27 • Number of events 1 • 3 months

Additional Information

Seth Pantanelli MD

Penn State Hershey Medical Center

Phone: 717-531-4696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place