NCT04059289

Brief Summary

To compare (low contrast) visual acuity (VA) and contrast sensitivity (CS) - both at intermediate distances under nighttime driving conditions in a driving simulator between patients with bilateral EYHANCE IOLs OR bilateral conventional monofocal IOLs. Visual function testing in the driving simulator will be assessed without AND with (static) glare. Additionally: Assessment of individual response times, scanpath characteristics, evaluation of test retest reliability and self-evaluation of (intermediate) vision and visual impairment related to glare.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 31, 2020

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 8, 2019

Last Update Submit

March 28, 2020

Conditions

Lenses, IntraocularPseudophakiaNear VisionDriving

Keywords

glarecontrast sensitivitydriving simulatorintermediate visual acuitypseudophakiaposterior chamber intraocular lensesbenchmarkstraylightnighttime driving

Outcome Measures

Primary Outcomes (2)

  • logVA

    logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)

    at least two months after uneventful intraocular lens implantation

  • logCS

    logarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20)

    at least two months after uneventful intraocular lens implantation

Secondary Outcomes (11)

  • Reproducibilities of logVA

    at least two months after uneventful intraocular lens implantation

  • Resonse times of logCS

    at least two months after uneventful intraocular lens implantation

  • Scanpath characteristics (I)

    at least two months after uneventful intraocular lens implantation

  • Scanpath characteristics (II)

    at least two months after uneventful intraocular lens implantation

  • Scanpath characteristics (III)

    at least two months after uneventful intraocular lens implantation

  • +6 more secondary outcomes

Study Arms (2)

Intraocular lens type I

Tecnis EYHANCE IOL (Johnson \& Johnson, New Brunswick/USA)

Other: Posterior chamber intraocular lens (IOL)

Intraocular lens type II

Clareon IOL (Alcon Pharma. Freiburg/FRG)

Other: Posterior chamber intraocular lens (IOL)

Interventions

Posterior chamber intraocular lens (IOL)OTHER

This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study

Also known as: Tecnis EYHANCE IOL (Johnson & Johnson, New Brunswick/USA), Clareon IOL (Alcon Pharma. Freiburg/FRG)
Intraocular lens type IIntraocular lens type II

Eligibility Criteria

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

Subjects of male or femal gender above the age of 18 years at least two months post surgery after bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL)

You may qualify if:

  • Informed consent
  • S.p. (at least two months post surgery) bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL)
  • Ophthalmological history normal, except cataract and uneventful IOL surgery
  • Distant visual high-contrast acuity \> 20/25 in either eye
  • Normal stereopsis (all figures of the LANG I random dot stereo test correctly recognized)

You may not qualify if:

  • Age below 18 years
  • Chronic eye disease (except cataract)
  • History of ocular surgery (except complication-free IOL surgery)
  • Visual pathway lesions
  • Strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences, Study Course Ophthalmic Optics

Aalen, Baden-Wurttemberg, 73430, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Two types of intraocular lenses

MeSH Terms

Conditions

PseudophakiaMyopia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRefractive ErrorsEye Diseases

Study Design

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

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 16, 2019

Study Start

January 7, 2020

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

March 31, 2020

Record last verified: 2019-08

Locations

DE(1)