NCT03247751

Brief Summary

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

Trial Health

100
On Track

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 Jun 2016

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

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

June 16, 2017

Last Update Submit

June 6, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • The intraocular lens rotation

    The angle of the intraocular rotation.

    postoperative 6 months

Secondary Outcomes (2)

  • visual acuity

    postoperative 6 months

  • Adverse event

    postoperative 6 months

Study Arms (1)

one group

EXPERIMENTAL

one group receiving NIDEK intraocular lens

Device: intraocular lens

Interventions

intraocular lensDEVICE

Implant NIDEK intraocular lens after cataract surgery

one group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

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

June 16, 2017

First Posted

August 14, 2017

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share