Clinical Evaluation of Toric Intraocular Lens | NCT03242486

Studies
Clinical Evaluation of Toric Intraocular Lens

NCT03242486

Sponsor

Nidek Co. LTD.

Status

Completed

Last Update Posted

Feb 20, 2018Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Cataract
Astigmatism

Interventions

toric intraocular lens

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014Actual

Primary Completion Date

May 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Aug 3, 2017

First Posted Date

Aug 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2018

Last Update Posted Date

Feb 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Label	Type	Description	Intervention Names
toric intraocular lens	Experimental	toric intraocular lens is implanted to all subjects	Device: toric intraocular lens

Name	Type	Description	Arm Group Labels	Other Names
toric intraocular lens	Device		toric intraocular lens

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35033047	Derived	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012030	Refractive Errors

ID	Term
D002386	Cataract
D001251	Astigmatism