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Clinical evaluation of Clareon multifocal IOL

Clinical evaluation of visual functions with Clareon PanOptix multifocal intraocular lenses in Japanese patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220042
Enrollment
60
Registered
2022-04-26
Start date
2022-05-10
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Cataract Ocular disease

Interventions

Implantation of Clareon PanOptix multifocal intraocular lenses in both eyes during surgery of bilateral cataract patients.

Sponsors

Bissen Hiroko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included in this study: 1) Patients who will undergo bilateral cataract surgery and are eligible for multifocal IOL implantation in both eyes. 2) Patients aged from 40 to 79 years when enrolled. 3) Patients whose preoperative corneal astigmatism of 1.0 D or less. 4) Patients whose postoperative corrected distance visual acuity is expected to be 0.5 or better.

Exclusion criteria

Exclusion criteria: 1) Patients with any ocular disease influencing visual function, except for cataract. 2) Patients with irregular corneal astigmatism. 3) Patients with history of intraocular or corneal surgery 4) Patients with other systemic or ophthalmic diseases considered to be unsuitable by an investigator.

Design outcomes

Primary

MeasureTime frame
Binocular distance-corrected visual acuities at distances of 40 cm, 60 cm, and 5 m at 3 months after bilateral implantation of intraocular lenses.

Secondary

MeasureTime frame
At 3 months after bilateral implantation of intraocular lenses: 1) Uncorrected and distance-corrected visual acuities at distances of 40 cm, 60 cm, 80 cm, and 5 m (monocular and binocular) 2) Binocular defocus curve 3) Binocular photopic contrast sensitivity 4) Preoperative and postoperative QOL questionnaire 5) Equivalence to previously reported data on the same type of intraocular lens made of AcrySof material in the above items Others; Postoperative subjective symptoms and its frequency and severity. Occurrences of adverse events and product deficiencies.

Contacts

Public ContactHiroko Bissen

Tokyo Dental Collage Suidobashi Hospital

bissen@tdc.ac.jp+81-3-5275-1856

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 5, 2026