SP2Y-GMF CLINICAL STUDY

Eguchi Shuichiro0 sites64 target enrollmentApril 2, 2021

ConditionsCataract D002386

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cataract
Sponsor: Eguchi Shuichiro
Enrollment: 64
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

April 2, 2021

End Date

August 20, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Eguchi Shuichiro

Eligibility Criteria

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