Clinical Evaluation of Toric Intraocular Lens

Nidek

Status: Completed

Conditions: Cataract; Astigmatism

Treatments: Device: toric intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03242486

TIOL-YST

Details and patient eligibility

About

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

Full 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

Enrollment: 64 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

toric intraocular lens

Experimental group

Description:

toric intraocular lens is implanted to all subjects

Treatment:

Device: toric intraocular lens