Evaluation of the Rotational Stability | NCT03247751

Studies
Evaluation of the Rotational Stability

NCT03247751

Sponsor

Nidek Co. LTD.

Status

Completed

Last Update Posted

Jun 7, 2023Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

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

Jun 2023

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

Jun 2016Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 14, 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

Jun 6, 2023

Last Update Posted Date

Jun 7, 2023Actual

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

To evaluate rotational stability of the investigational device implanted after cataract surgery.

Detailed Description

The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

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

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one group	Experimental	one group receiving NIDEK intraocular lens	Device: intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraocular lens	Device	Implant NIDEK intraocular lens after cataract surgery	one group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The intraocular lens rotation	The angle of the intraocular rotation.	postoperative 6 months

Secondary Outcomes

Measure	Description	Time Frame
visual acuity	Distance BCVA	postoperative 6 months
Adverse event	severity and causal relationship	postoperative 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, 18 years or older
Subject who diagnosed unilateral or bilateral age-related cataract.
Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
Calculated IOL power in within the range of investigational IOL.
Subject is able to understand, agree and sign the informed consent statement.
Subject is able and willing to comply with the postoperative follow-up examination schedule.

Exclusion Criteria:

Uncontrolled systemic or ocular disease.
Extremely shallow anterior chamber.
Previous intraocular and corneal surgery.
Traumatic cataract.
Pregnancy or lactation.
Concurrent participation in another drug and device clinical investigation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007910	Lenses, Intraocular

Ancestor Terms

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies
D019736	Prostheses and Implants

Browse Leaves

Not provided

Browse Branches

Not provided