NCT03242486CompletedNot Applicable
Safety and Effectiveness Evaluation of Toric Intraocular Lens
Nidek Co. LTD.0 sites64 target enrollmentStarted: December 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Primary Endpoint
- Visual acuity
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
toric intraocular lens
Experimental
toric intraocular lens is implanted to all subjects
Intervention: toric intraocular lens (Device)
Outcomes
Primary Outcomes
Visual acuity
Time Frame: postoperative 6 months
Visual acuity with pre-determined spherical correction
Secondary Outcomes
- IOL rotation(postoperative 6 months)
- Visual acuity(postoperative 6 months)
Investigators
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