A Study Assessing Safety and Efficacy of MD-15 Intraocula... | NCT02888210

Studies
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery

NCT02888210

Sponsor

Santen Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

110Actual

Phase

Phase 3

Conditions

Cataract

Interventions

MD-15 Intraocular Lens

Countries

Japan

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

Sep 3, 2016Actual

Primary Completion Date

Nov 22, 2017Actual

Completion Date

Nov 22, 2017Actual

First Submitted Date

Aug 30, 2016

First Submission Date that Met QC Criteria

Aug 30, 2016

First Posted Date

Sep 2, 2016Estimated

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 25, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MD-15	Experimental	Investigational intraocular lens	Device: MD-15 Intraocular Lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MD-15 Intraocular Lens	Device		MD-15

Measure	Description	Time Frame
Corrected visual acuity		Week 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who intend to undergo phacoemulsification cataract extraction

Exclusion Criteria:

Patients who undergo secondary implantation
Patients with vision loss induced by causes other than cataract
Patients who the principal investigator/subinvestigator considers ineligible for enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases