Status:
COMPLETED
Clinical Evaluation of Toric Intraocular Lens
Lead Sponsor:
Nidek Co. LTD.
Conditions:
Cataract
Astigmatism
Eligibility:
All Genders
40+ years
Phase:
NA
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 Eq...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03242486
Start Date
December 1 2014
End Date
December 1 2017
Last Update
February 20 2018
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