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Monovision of refractive EDOF intraocular lens

Effectiveness of monovision with refractive extended depth-of-focus intraocular lens

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCTs032250336
Enrollment
60
Registered
2025-09-03
Start date
2025-09-09
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

Sponsors

Bissen Hiroko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who undergo bilateral cataract surgeries with PureSee intraocular lens implantation in both eyes. 2) Age between 20 and 85 years. 3) Axial length over 22.0 mm and under 27.0 mm 4) Preoperative corneal astigmatism of 2.5 D or less. 5) Postoperative corrected distance visual acuity of 0.8 or better

Exclusion criteria

Exclusion criteria: 1) Other ocular diseases influencing visual function, such as uveitis, external/internal infection, diabetes retinopathy, glaucoma, exfoliation syndrome, pathological miosis, keratoconus, corneal dystrophy, and zonule weakness. 2) History of ophthalmic surgery. 3) Corneal irregular astigmatism 4) Failure of intraocular lens fixation in the capsule owing to Intraoperative zonular dehiscence, posterior capsule rapture, vitreous prolapse, hyphema. 5) Other systemic or ophthalmic diseases considered unsuitable by an investigator.

Design outcomes

Primary

MeasureTime frame
At 3 months postoperatively, 1. Binocular visual acuity at 40 cm in monovision cases; 2. Binocular uncorrected distance visual acuity in monovision cases.

Secondary

MeasureTime frame
Three months postoperative comparisons of 1) Binocular uncorrected depth of defocus 2) Binocular uncorrected contrast sensitivity 3) Stereopsis 4) QOV questionnaire 5) Use of spectacles and night photopsia

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: Jul 3, 2026