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

Terminated

• Conditions: Cataract

• 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

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 intermediate visual acuity	3 months	Binocular distance-corrected intermediate visual acuity
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

Trial Locations

Locations (1)

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