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Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

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Subjects in this study had a higher rate of female participants (78.1%) compared with male participants (21.9%) was observed in the study. An overall mean age of 65.2 years, a majority of subjects were 60-79 years of age (60-69 years:10 subjects, 70-79 years: 13 subjects). There were 8 subjects under the age of 60 and 1 subject was in the age category of 80 years or older.

Date of consent acquisition from the first subject: 01 December, 2020 Date of follow-up completion for the last subject: 10 August, 2021

There were 6 ocular AEs out of 41 eyes reported in the study, all relating to IOP increase with onset of 1 day postoperative and resolved within approximately 1 week of onset. All events were not related to the study device but related to the test procedure (operative). There were no AEs of implantation with test article and no serious ocular AEs reported in the study. There were no serious non-ocular AEs, including deaths, reported in the study. In addition, no Adverse Device Effects were reported in the study.

Primary Effectiveness: The percentage of eyes with <=0.25 D of absolute refractive cylinder at Visit 3/3A (Day 30-60) is 90.2% (37/41 eyes), and that was above the historical threshold rate (29.2%) (P<0.0001 from Exact Test of Binomial Proportion). Secondary Effectiveness Endpoints: All eyes (41/41 eyes) in the study were with <=0.5 D of residual refractive cylinder at Visit 3/3A (Day 30-60). An observed mean (SD) of absolute manifest refractive cylinder was 0.055 (0.153)D for the All Implanted analysis set at Visit 3/3A (Day 30-60).

The primary endpoint of this study was the percentage of eyes with <=0.25 D cylinder power at 1-2 months postoperative. The percentage of eyes with <=0.25 D of absolute refractive cylinder was 90.2% at Visit 3/3A (Day 30-60), showing a significant difference from the historical threshold calculated based on the past studies using non-toric IOLs. No AEs related to the study device were reported. No subjects discontinued the study due to AEs, and there were no safety concerns of the study device.

Oct. 17, 2022

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2032200147

Bissen-Miyajima Hiroko

Tokyo Dental College Suidobashi Hospital

2-9-18 Kandamisaki-cho, chiyoda-ku, Tokyo

bissen@tbc.ac.jp

Hasegawa Koji

Alcon Japan, Ltd.

1-23-1 Toranomon, Minato-ku, Tokyo

+81-3-6899-5061

clinicalstudy.japan@alcon.com

Complete

Oct. 12, 2020

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye as determined by a new Alcon Toric calculator.
- Planned postoperative emmetropia (spherical equivalent +-0.50 D).
- Other protocol-specified inclusion criteria may apply.

- Irregular corneal astigmatism.
- History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology.
- Glaucoma; ocular hypertension; diabetic retinopathy; any optic nerve pathology.
- History of previous intraocular or corneal (refractive or trauma related) surgery.
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and LASIK.
- Other protocol-defined exclusion criteria may apply.

Both

Cataract

Cataract surgery

D002386

D002387

Percentage of eyes with <= 0.25 diopter (D) refractive cylinder at Visit 3/3A (Day 30-60).

- Percentage of eyes with <= 0.5 D refractive cylinder at Visit 3/3A (Day 30-60).
- Average manifest refractive cylinder at Visit 3/3A (Day 30-60).

+81-3-3262-3421

Sept. 15, 2020

none