Trial Outcomes & Findings for Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens (NCT NCT04124952)

Results Overview

Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) 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

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Panoptix Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Panoptix Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Age, Continuous	58 years STANDARD_DEVIATION 7 • n=29 Participants
Sex: Female, Male Female	17 Participants n=29 Participants
Sex: Female, Male Male	12 Participants n=29 Participants
Region of Enrollment United States	29 participants n=29 Participants

PRIMARY outcome

Timeframe: 3 months

Population: This is the number of emmetropic subjects (subgroup)

Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) 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=21 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Number of Emmetropic Subjects Who Are Spectacle Independent	21 Participants

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR uncorrected distance visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Uncorrected Distance Visual Acuity	0.07 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR uncorrected intermediate visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Uncorrected Intermediate Visual Acuity	0.09 logMAR Standard Deviation 0.13

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR uncorrected near visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Uncorrected Near Visual Acuity	0.07 logMAR Acuity Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR corrected distance visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Corrected Distance Visual Acuity	0.03 logMAR Acuity Standard Deviation 0.07

SECONDARY outcome

Timeframe: 3 months

Binocular distance-corrected intermediate visual acuity in logMAR

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Distance-corrected Intermediate Visual Acuity	0.06 logMAR Acuity Standard Deviation 0.10

SECONDARY outcome

Timeframe: 3 months

Binocular logMAR distance-corrected near visual acuity

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Binocular Distance-corrected Near Visual Acuity	0.05 logMAR Acuity Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 months

Spherical equivalent refraction in diopters

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Spherical Equivalent Refraction	0.06 diopters Standard Deviation 0.53

SECONDARY outcome

Timeframe: 3 months

Residual refractive cylinder in diopters

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Residual Refractive Cylinder	0.49 diopters Standard Deviation 0.36

SECONDARY outcome

Timeframe: 3 months

Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Quality of Vision Questionnaire Frequency	36.9 Score on a scale (0-100, 0 is best) Standard Deviation 16.6
Quality of Vision Questionnaire Severity	30.6 Score on a scale (0-100, 0 is best) Standard Deviation 15.1
Quality of Vision Questionnaire Degree of bother	28.7 Score on a scale (0-100, 0 is best) Standard Deviation 20.7

SECONDARY outcome

Timeframe: 3 months

percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time")

Outcome measures

Outcome measures
Measure	Panoptix n=29 Participants Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Overall Spectacle Independence	29 Participants

Adverse Events

Panoptix

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Panoptix n=30 participants at risk Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Musculoskeletal and connective tissue disorders Bicycle accident	3.3% 1/30 • Number of events 1 • 3 months

Additional Information

Andrew Shatz, MD

SightTrust Eye Institute

Phone: 877.878.7890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place