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Clinical Evaluation of Toric Intraocular Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03242486
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.

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

Condition or disease Intervention/treatment Phase
Cataract Astigmatism Device: toric intraocular lens Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Evaluation of Toric Intraocular Lens
Actual Study Start Date : December 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: toric intraocular lens
toric intraocular lens is implanted to all subjects
Device: toric intraocular lens



Primary Outcome Measures :
  1. Visual acuity [ Time Frame: postoperative 6 months ]
    Visual acuity with pre-determined spherical correction


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: postoperative 6 months ]
    UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent

  2. IOL rotation [ Time Frame: postoperative 6 months ]
    angle of rotation


Other Outcome Measures:
  1. Adverse events [ Time Frame: one year ]
    Severity and causal relationship



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT03242486     History of Changes
Other Study ID Numbers: TIOL-YST
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors