1 year Clinical evaluation of visual functions with Clareon PanOptix

1 year Clinical evaluation of visual functions with Clareon PanOptix - 1 year Clinical evaluation of visual functions with Clareon PanOptix

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055208

Enrollment

Registered

2024-09-01

Start date

2022-11-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Binocular Age related Cataract patients scheduled to insert Clareon PanOptix/ Clareon PanOptix Toric (T2-T6) in both eyes Normal range of Axial lengths biometry from 22.0 mm to 26.5 mm (no long/short eyes) Patients expected to visit the site until 12 months after surgery

Exclusion criteria

Exclusion criteria: Any disease (patients with retinal disease, glaucoma or dry eye) that affects endpoints other than cataract Corneal irregular astigmatism Previous intraocular or refractive surgery Disqualified by the investigator because of physical or ophthalmic diseases

Design outcomes

Primary

Measure	Time frame
binocular best corrected visual acuity (5m) at 12 months post-op	—

Secondary

Measure	Time frame
Visual acuity (5 m, 60 cm, 40 cm) :1 month, 6 months, 12 months after surgery Uncorrected monocular visual acuity Monocular distance corrected visual acuity Binocular uncorrected visual acuity Binocular distance-corrected visual acuity Quality of Life Questionnaire preoperative, 1, 6, and 12 months postoperative Refractive error at 1, 6, and 12 months postoperatively Evaluate the degree of safety information if any of the following are observed Gristining at 1, 6, and 12 months postoperatively Posterior cataracts at 1, 6, and 12 months postoperatively	—

Measure

Time frame

Visual acuity (5 m, 60 cm, 40 cm) :1 month, 6 months, 12 months after surgery Uncorrected monocular visual acuity Monocular distance corrected visual acuity Binocular uncorrected visual acuity Binocular distance-corrected visual acuity Quality of Life Questionnaire preoperative, 1, 6, and 12 months postoperative Refractive error at 1, 6, and 12 months postoperatively Evaluate the degree of safety information if any of the following are observed Gristining at 1, 6, and 12 months postoperatively Posterior cataracts at 1, 6, and 12 months postoperatively

—

Countries

Japan

Contacts

Public ContactEmi Itami

Fujita Eye Clinic None

itami@fujitaec.or.jp0886561010

Outcome results