NCT04800887

Brief Summary

To compare visual outcomes for various distances, reading speed, contrast sensitivity, glare occurence, defocus curve and subjective satisfaction in patients implanted with the extended depth of focus lens (Tecnis Eyhance) in one eye and monocal aspheric lens (Tecnis ZCB00) in second eye. Patients undergo visit in 3,6 and 12 months after the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

March 9, 2021

Last Update Submit

October 10, 2021

Conditions

Intraocular Lens

Keywords

EDOF lensCataract

Outcome Measures

Primary Outcomes (4)

  • Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL

    * uncorrected distance visual acuity (UDVA) * corrected distance visual acuity (CDVA) * uncorrected near visual acuity (UNVA) * distance corrected near visual acuity (DCNVA) * corrected near visual acuity (CNVA) * uncorrected intermediate visual acuity (UIVA) * distance corrected intermediate visual acuity (DCIVA)

    12 months

  • Comparison of reading speed between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL

    Monocular reading speed (Salzburg reading desk for 66cm and 80cm)

    12 months

  • Difference in contrast sensitivity between eyes with EDOF IOL and monofocal IOL

    Contrast sensitivity - CSV (contrast sensitivity vision) 1000 device- monocularly, mesopic, without glare Contrast sensitivity measurement on Glaretester- monocularly- with and without glare

    12 months

  • Comparison of defocus curve between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL

    A defocus curve that measures visual acuity should be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 increments from +1.5 to -2.5 diopter with spherical plus and spherical minus trial lenses (i.e.,+1.5 D, +1.0 D, +0.5 D, 0.00 D, -0.5 D, -1.00 D, . . . ,-2.50 D) with visual acuity recorded at each change in correction.

    6 months

Secondary Outcomes (4)

  • Questionaire

    6 months

  • Change in intermediate visual acuity in eyes implanted with EDOF IOL

    3 and 12 months

  • Change in reading speed in eyes implanted with EDOF IOL

    3 and 12 months

  • Change in contrast sensitivity in eyes implanted with EDOF IOL

    3 and 12 months

Study Arms (2)

Extended depth of focus intraocular lens

ACTIVE COMPARATOR

Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance

Device: TECNIS Eyhance intraocular lens

Monofocal intraocular lens

ACTIVE COMPARATOR

Eyes of patients implanted with monofocal lens Tecnis ZCB00

Device: Monofocal intraocular lens Tecnis ZCB00

Interventions

TECNIS Eyhance intraocular lensDEVICE

Cataract surgery and implantation with extended depth of focus intraocular lens

Extended depth of focus intraocular lens
Monofocal intraocular lens Tecnis ZCB00DEVICE

Cataract surgery and implantation with monofocal intraocular lens

Monofocal intraocular lens

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of cataract in both eyes
  • no other ocular pathology affecting visual acuity
  • bilateral phacoemulsification cataract surgery was arranged for both eyes
  • corneal astigmatism up to 0,75 cylinder (measured by IOL Master biometry)
  • dioptric power of both selective lens within 1,5 D range in one patient
  • selecting IOL power between 18 D and 27 D power range

You may not qualify if:

  • complicated cataract
  • corneal opacities or irregularities
  • amblyopia
  • anisometropia
  • coexisting ocular pathologies
  • glaucoma
  • history of ocular surgery
  • refusal or unable to maintain follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty hospital Kralovske Vinohrady

Prague, Czech Republic, 11000, Czechia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Andrea Janekova, MD

    Faculty Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double masked- patient and investigator are masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 16, 2021

Study Start

November 12, 2019

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)