Clinical Evaluation of Toric Intraocular Lens

Not Applicable

Completed

• Conditions: Astigmatism; Cataract
• Interventions: Device: toric intraocular lens

• Registration Number: NCT03242486
• Lead Sponsor: Nidek Co. LTD.

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

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2017-05
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-18
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

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

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.

Exclusion Criteria

• Disorder of corneal endothelium
• Uncontrolled glaucoma
• Active Uveitis
• Diabetic retinopathy
• Retinal detachment
• Congenital ocular anomalies
• Choroidal hemorrhage
• Shallow anterior chamber
• Microphthalmus
• Corneal dystrophy
• Optic atrophy
• Ocular hypertension
• Amblyopia
• Previous history of corneal transplantation
• Active Iritis
• Corneal disorder
• Macular degeneration
• Retinal degeneration
• Clinically significant change in macula and/or retinal pigment epithelium
• Corneal irregular astigmatism
• Atopic disease
• Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
• Pseudo-exfoliation syndrome
• Iris neovascularization
• Long axis length eye (axis length : 28mm or more)
• Severe dry eye, abnormality of the lens surface
• Concurrent participation in another drug and device clinical investigation
• Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
• Patient who is judged inappropriate by investigators or sub-investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
toric intraocular lens	toric intraocular lens	toric intraocular lens is implanted to all subjects

Primary Outcome Measures

Name	Time	Method
Visual acuity	postoperative 6 months	Visual acuity with pre-determined spherical correction

Secondary Outcome Measures

Name	Time	Method
IOL rotation	postoperative 6 months	angle of rotation
Visual acuity	postoperative 6 months	UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent