Safety and Effectiveness Evaluation of Toric Intraocular Lens

Nidek Co. LTD.0 sites64 target enrollmentDecember 2014

ConditionsCataract Astigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Nidek Co. LTD.
Enrollment: 64
Primary Endpoint: Visual acuity
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.

Detailed Description

Effectiveness * primary endpoint is visual acuity with pre-determined spherical correction. * secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation Safety * number and percentage of adverse event

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nidek Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with age of 40 years or older
•Patients with age-related cataract in one eye or both eyes.
•Patients willing to participate in the required postoperative study.
•Patient who can understand and sign the consent document.
•An eye whose pupil diameter after mydriasis is 5 mm or greater.
•An eye whose preoperative corneal cylindrical power is 1.0D or more.
•An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
•An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.