Clinical Evaluation of Toric Intraocular Lens

February 18, 2018 updated by: Nidek Co. LTD.

Safety and Effectiveness Evaluation of Toric Intraocular Lens

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: toric intraocular lens
toric intraocular lens is implanted to all subjects
Device: toric intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: postoperative 6 months
Visual acuity with pre-determined spherical correction
postoperative 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: postoperative 6 months
UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent
postoperative 6 months
IOL rotation
Time Frame: postoperative 6 months
angle of rotation
postoperative 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: one year
Severity and causal relationship
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nidek Co. LTD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2014

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (ACTUAL)

August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 18, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIOL-YST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on toric intraocular lens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe