Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens

Terminated

• Conditions: Cataract
• Interventions: Device: Panoptix Toric

• Registration Number: NCT04128514
• Lead Sponsor: Eye Center of North Florida

Brief Summary

The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery.

Detailed Description

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Study Timeline

• Study First Submitted: 2019-10-10
• Study Start: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Status Verified: 2022-03
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled subjects	Panoptix Toric	Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation. The Acrysof (R) Panoptix (R) Toric intraocular lens will be implanted in both eyes of subjects.

Primary Outcome Measures

Name	Time	Method
Spectacle independence - emmetropia	3 months	Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")

Secondary Outcome Measures

Name	Time	Method
Binocular uncorrected intermediate visual acuity	3 months	Binocular intermediate visual acuity
Binocular uncorrected distance visual acuity	3 months	Binocular distance visual acuity
BInocular uncorrected near visual acuity	3 months	Binocular near visual acuity
Monocular corrected distance visual acuity	3 months	Monocular corrected distance visual acuity
VFQ-14	3 months	Questionnaire responses on VFQ-14 visual function questionnaire
Binocular best-corrected distance visual acuity	3 months	Binocular best-corrected distance visual acuity
Uncorrected preferred reading distance	3 months	Uncorrected preferred reading distance
Binocular distance-corrected near visual acuity	3 months	Binocular distance-corrected near visual acuity
Spherical equivalent refraction	3 months	Spherical equivalent refraction
Spectacle independence - overall	3 months	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")
Residual astigmatism	3 months	Residual astigmatism
Choose lens again	3 months	Percent of patients who would choose this lens modality again.
Binocular uncorrected visual acuity at preferred reading distance	3 months	Binocular uncorrected visual acuity at preferred reading distance
Binocular distance-corrected intermediate visual acuity	3 months	Binocular distance-corrected intermediate visual acuity

Trial Locations

Locations (1)

Eye Center of North Florida; 🇺🇸 Panama City, Florida, United States