NCT04126187

AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

Completed Results posted Last updated 21 September 2023

What this trial tests

trial testing Panoptix in Cataract in 30 participants. Completed in 30 March 2021.

Timeline

14 May 2020

Primary endpoint
30 March 2021

30 March 2021

Quick facts

Lead sponsor	Gainesville Eye Associates
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	14 May 2020
Primary completion	30 March 2021
Estimated completion	30 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Panoptix

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Gainesville Eye Associates

Who can join

40 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Have Spectacle Independence Primary · 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")

Group	Value	95% CI
Panoptix	27

Binocular Uncorrected Distance Visual Acuity Secondary · 3 months

Binocular uncorrected distance visual acuity in logMAR

Group	Value	95% CI
Panoptix	.09	± .09

Binocular Uncorrected Intermediate Visual Acuity Secondary · 3 months

Binocular uncorrected intermediate visual acuity in logMAR

Group	Value	95% CI
Panoptix	0	± .1

Binocular Uncorrected Near Visual Acuity Secondary · 3 months

Binocular logMAR uncorrected near visual acuity

Group	Value	95% CI
Panoptix	.03	± .11

Binocular Best-corrected Distance Visual Acuity Secondary · 3 months

Binocular logMAR best-corrected distance visual acuity

Group	Value	95% CI
Panoptix	.02	± .05

Binocular Distance-corrected Intermediate Visual Acuity Secondary · 3 months

Binocular distance-corrected logMAR intermediate visual acuity

Group	Value	95% CI
Panoptix	-.02	± .09

Binocular Distance-corrected Near Visual Acuity Secondary · 3 months

Binocular logMAR distance-corrected near visual acuity

Group	Value	95% CI
Panoptix	-.01	± .07

Spherical Equivalent Refraction Secondary · 3 months

Spherical equivalent refraction in diopters

Group	Value	95% CI
Panoptix	-.02	± .35

Residual Refractive Cylinder Secondary · 3 months

Residual refractive cylinder in diopters

Group	Value	95% CI
Panoptix	0.21	± .28

Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup Secondary · 3 months

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

Group	Value	95% CI
Panoptix	21

Sponsor's own description

The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reported Patient Satisfaction and Spectacle Independence Following Bilateral Implantation of the PanOptix^® Trifocal Intraocular Lens.
   Blehm C, Potvin R. · · 2021 · cited 18× · PMID 34262250 · DOI 10.2147/opth.s323337