Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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toric intraocular lens
toric intraocular lens is implanted to all subjects
toric intraocular lens
Interventions
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toric intraocular lens
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Nidek Co. LTD.
INDUSTRY
Responsible Party
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References
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Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
Other Identifiers
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TIOL-YST
Identifier Type: -
Identifier Source: org_study_id
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