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NSP-3 rotation amount study

A Single-Center, Open-Label, Randomized, Parallel Group Comparison Study to Evaluate the Rotation Amount of Intraocular Lens NSP (NSP-3) Compared to NP (NP-1) After Cataract Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072240008
Enrollment
60
Registered
2024-04-22
Start date
2024-06-10
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 Cataract

Interventions

Group A: Implantation of NSP-3 Group B: Implantation of NP-1
D060437

Sponsors

Mori Yosai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed with bilateral or unilateral cataract and planned cataract removal by phacoemulsification 2)Patients with an axial length between 22 mm and 26 mm in the study eye(s) 3)Patients who may dilate pupil sufficiently for IOL fixation imaging 4)Patients with an expected postoperative BCDVA of 0.7 or better 5)Patients who are able to understand the explanation and sign informed consent voluntary 6)Patients who can visit postoperative observation 7)Patients aged 18 years or older when obtaining consent

Exclusion criteria

Exclusion criteria: 1)Patients planned simultaneous surgery such as vitrectomy and cataract surgery 2)Patients with ocular diseases other than cataract that affect visual function or IOL fixation (e.g. exfoliation syndrome, retinitis pigmentosa, shallow chamber) 3)Patients with previous intraocular surgery 4)Patients considered to be unsuitable by an investigator

Design outcomes

Primary

MeasureTime frame
The IOL rotation amount between postoperative day 0 and 1 month, which is calculated from IOL fixation images

Secondary

MeasureTime frame
Uncorrected visual acuity, Best corrected visual acuity, Subjective refraction, Objective refraction

Contacts

Public ContactAkiko Yagi

Miyata Eye Hospital

officeplusi2012@gmail.com+81-986-22-1441

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026