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Visual Function at Near, Intermediate, and Distance Using Diffractive Trifocal Intraocular Lenses in Bilateral Age-Related Cataract (VISION-3 Study): VISION-3 Pilot Study (VISION-3 Pilot Study)

Visual Function at Near, Intermediate, and Distance Using Diffractive Trifocal Intraocular Lenses in Bilateral Age-Related Cataract: The VISION-3 Pilot Study (VISION-3 Pilot Study)

Negishi Kazuno

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

kazunonegishi@keio.jp

Torii Hidemasa

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5363-3821

htorii@keio.jp

Recruiting

Sept. 25, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients scheduled for bilateral intraocular lens implantation via phacoemulsification due to age-related cataracts
2) Patients who wish to receive either the study product (Clareon PanOptix, 1 type for both eyes) or the control products (Vivinex Gemetric and Vivinex Gemetric Plus, 2 types, one eye each) for emmetropic targeting
3) Patients judged by the principal investigator or sub-investigator to have a postoperative best-corrected visual acuity of logMAR 0.1 or better expected in both eyes
4) Patients for whom postoperative refractive astigmatism is predicted to be within 0.5 D in both eyes using a non-TORIC model or a TORIC T3 to T5 model
5) Patients aged 18 years or older at the time of consenting
6) Patients who can provide written consent for participation in this study

1) Patients who wish to receive only one the study product or the control products, or who do not wish to be randomly assigned to receive either product
2) Patients with irregular corneal astigmatism
3) Patients with ocular diseases affecting postoperative visual acuity (e.g., severe dry eye, retinal disease, glaucoma, keratoconus)
4) Patients with a history of ocular surgery, including corneal refractive surgery
5) Patients desiring monovision after surgery
6) Patients with reduced stereoscopic visual function due to a history of amblyopia or monocular fixation syndrome
7) Patients scheduled for other simultaneous procedures during cataract surgery
8) Patients with nystagmus, strabismus, or laxity or rupture of the Zinn's ligament
9) Patients with ocular infection or inflammation
10) Patients with other conditions deemed unsuitable for participation in this study by the principal investigator or sub-investigator

Both

age-related cataract

Group A: insert Clareon PanOptix in both eyes
Group B: insert Vivinex Gemetric and Vivinex Gemetric Plus in each eye, respectively

intraocular lens

D002386

D007910

Binocular intermediate visual acuity (60cm) under correction at far distance at 2 months post-surgery

The following photopic visual function at 2 months post-surgery
1) Best-corrected binocular visual acuity (5m), binocular near visual acuity (40 & 33 cm) under correction at far distance
2) Uncorrected binocular far visual acuity (5m), uncorrected binocular intermediate visual acuity (60 cm), uncorrected binocular near visual acuity (40 & 33 cm)
3) Binocular depth of focus curve (measured range: +1.00D to -3.00D in 0.50D increments; +/-0.50 range measured in 0.25D increments)
4) Postoperative subjective refractive status (spherical power, cylindrical power, equivalent spherical value)

+81-3-5363-3503

Aug. 03, 2026

No

none

none