NCT03145116

Brief Summary

Clinical safety and efficacy of CT ASPHINA 509 IOLs after implantation

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
Last Updated

July 18, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

May 5, 2017

Last Update Submit

July 17, 2018

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Monocular best corrected distance visual acuity

    12 to 18 months after surgery

Study Arms (1)

509

EXPERIMENTAL
Device: CT ASPHINA 509

Interventions

CT ASPHINA 509DEVICE

Intraocular lens

509

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
  • Patients of any gender
  • Assured follow-up examinations
  • Biometry measurement preferably compatible with the IOLMaster evaluation;
  • IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
  • Patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract)

You may not qualify if:

  • BCVA not available preoperatively or better than 0.3 logMAR pre-op
  • Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial
  • Patients whose freedom is impaired by administrative or legal order
  • Concurrent participation in another drug or device investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklinink

Ahaus, 12593, Germany

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Study Start

September 22, 2017

Primary Completion

February 5, 2018

Study Completion

February 5, 2018

Last Updated

July 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)