Clinical Study to Evaluate the Safety and Performance of the Intraocular Lens (Investigational Device Development Code: SP2Y-GMF) After Implantation.

Phase 3

• Conditions: Cataract; D002386

• Registration Number: JPRN-jRCT2072210002
• Lead Sponsor: Eguchi Shuichiro

Brief Summary

The investigational device was shown to be effective and safe for correcting visual acuity at far, intermediate and near distances and reducing astigmatism in aphakia after cataract operation.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-02
• Study Completion: 2022-08-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1) Patients with bilateral cataract, aged 22 or more years at the time of consent
2) Patients who desire to receive bilateral cataract surgery and implantation
3) Patients with planned 2nd eye surgery within the period of 7-30 days after the 1st eye surgery
4) Other patients who meet the inclusion crirteria stipulated in the clinical trial protocol

Exclusion Criteria

1) Patients with history of corneal transplant
2) Patients with history of refractive surgery
3) Patients with history of intraocular surgery
4) Patients with glaucoma
5) Patients with previous or acute retinal detachment
6) Patients with retinal degenerative disorders
7) Patients with a plan to have an intraocular surgery other than implantation of the investigational devices during the study period
8) Other patients who meet the exclusion crirteria stipulated in the clinical trial protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance<br>1) Percentage of eyes with Uncorrected Near Visual Acuity 0.5 or more decimal at Month 4-6<br>2) Percentage of eyes with subjective astigmatism 0.50D or less at Month 4-6 in all eyes implanted with minimum cylinder power lens