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Clinical Trials/NCT03242486
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

Sponsor
Nidek Co. LTD.
Sponsor Class
Industry
Responsible Party
Sponsor

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