NSP-3 rotation amount study

JRCT ID: jRCTs072240008

Registered date:22/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 10/06/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: The IOL rotation amount between postoperative day 0 and 1 month, which is calculated from IOL fixation images
• Secondary Outcome: Uncorrected visual acuity, Best corrected visual acuity, Subjective refraction, Objective refraction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mori Yosai
• Source(s) of Monetary Support: NIDEK CO., LTD.