NCT04037631

Brief Summary

Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

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

Study Start

First participant enrolled

July 20, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

July 26, 2019

Last Update Submit

January 26, 2021

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Corrected distance visual acuity (CDVA)

    Evaluation of CDVA obtained with diagnostic device

    3 months after surgery

Study Arms (1)

Patients without clinically significant age-related cataract

Diagnostic Test: Diagnostic device

Interventions

Diagnostic deviceDIAGNOSTIC_TEST

Diagnostic test

Patients without clinically significant age-related cataract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without clinically significant age-related cataract

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, aged 18 years to open age
  • Assured follow-up examinations
  • Healthy eyes without clinically significant age-related cataract

You may not qualify if:

  • Patients unable to meet the limitations of the protocol or likely of non-cooperation 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)

Internationale Innovative Ophthalmologie

Düsseldorf, 40549, Germany

Location

Related Publications (1)

  • Schallhorn SC, Fernandez J, Kaymak H, Gerlach M, Kirchner FO. Prediction of visual outcomes using virtual implantation of a trifocal intraocular lens in presbyopic lens exchange patients. J Cataract Refract Surg. 2025 Feb 1;51(2):133-140. doi: 10.1097/j.jcrs.0000000000001576.

    PMID: 39453845DERIVED

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

July 20, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)