Trial Outcomes & Findings for AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study (NCT NCT04126187)

Results Overview

Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time")

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

3 months

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Panoptix Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Age, Continuous	67 years STANDARD_DEVIATION 10 • n=30 Participants
Sex: Female, Male Female	22 Participants n=30 Participants
Sex: Female, Male Male	8 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 3 months

Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time")

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Number of Participants Who Have Spectacle Independence	27 Participants

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected distance visual acuity in logMAR

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Uncorrected Distance Visual Acuity	.09 logMAR Standard Deviation .09

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected intermediate visual acuity in logMAR

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Uncorrected Intermediate Visual Acuity	0 logMAR Standard Deviation .1

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR uncorrected near visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Uncorrected Near Visual Acuity	.03 logMAR Standard Deviation .11

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR best-corrected distance visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Best-corrected Distance Visual Acuity	.02 logMAR Standard Deviation .05

SECONDARY outcome

Timeframe: 3 months

Binocular distance-corrected logMAR intermediate visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Distance-corrected Intermediate Visual Acuity	-.02 logMAR Standard Deviation .09

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR distance-corrected near visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Binocular Distance-corrected Near Visual Acuity	-.01 logMAR Standard Deviation .07

SECONDARY outcome

Timeframe: 3 months

Spherical equivalent refraction in diopters

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Spherical Equivalent Refraction	-.02 diopters Standard Deviation .35

SECONDARY outcome

Timeframe: 3 months

Residual refractive cylinder in diopters

Outcome measures

Outcome measures
Measure	Panoptix n=30 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Residual Refractive Cylinder	0.21 diopters Standard Deviation .28

SECONDARY outcome

Timeframe: 3 months

Population: This is the number of patients that had a refractive target within 0.50D of intended (emmetropia subgroup)

Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction

Outcome measures

Outcome measures
Measure	Panoptix n=22 Participants Bilateral implantation of the Panoptix trifocal IOL Panoptix: Panoptix trifocal intraocular lens (IOL)
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup	21 Participants

Adverse Events

Panoptix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clayton Blehm, MD

Gainesville Eye Associates

Phone: 17705324444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place