NCT02888210

Brief Summary

To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

September 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

August 30, 2016

Last Update Submit

February 25, 2018

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Corrected visual acuity

    Week 52

Study Arms (1)

MD-15

EXPERIMENTAL

Investigational intraocular lens

Device: MD-15 Intraocular Lens

Interventions

MD-15 Intraocular LensDEVICE
MD-15

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who intend to undergo phacoemulsification cataract extraction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 2, 2016

Study Start

September 3, 2016

Primary Completion

November 22, 2017

Study Completion

November 22, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

JP(1)