NCT05041881

Brief Summary

To compare visual outcomes, contrast sensitivity, glare occurrence, incidence of posterior capsule opacification (PCO) and subjective satisfaction in patients implanted with trifocal, accommodating and monofocal lens in long term period.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
2 countries

2 active sites

Status
unknown

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

September 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

September 8, 2021

Last Update Submit

September 26, 2021

Conditions

Intraocular Lens

Keywords

trifocal lensaccommodating lensmonofocal lensoptical phenomenaglare

Outcome Measures

Primary Outcomes (5)

  • Comparison of visual acuity for distance between groups

    uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA)

    36-48 months after surgery

  • Comparison of visual acuity for intermediate between groups

    Uncorrected intermediate visual acuity (UIVA) Distance corrected intermediate visual acuity (DCIVA)

    36-48 months after surgery

  • Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens)

    uncorrected near visual acuity (UNVA)

    36-48 months after surgery

  • Contrast sensitivity comparison between groups

    Photopic contrast sensitivity with glare Mesopic contrast sensitivity with glare Mesopic contrast sensitivity without glare

    36-48 months after surgery

  • Incidence of posterior capsule opacification (PCO)

    Incidence of PCO and needed Nd YAG capsulotomy treatment in each group

    36-48 months after surgery

Study Arms (3)

Trifocal IOL group

ACTIVE COMPARATOR

Patients implanted during cataract or refractive surgery with trifocal lens, which allowed to see for far, intermediate and near distance, but due to optic design having unwanted effect like optical phenomena and lower contrast sensitivity

Device: Trifocal lens AT LISA TRI, Zeiss

Accommodating IOL group

ACTIVE COMPARATOR

Patients implanted during cataract or refractive surgery with accommodating lens, which allowed to see for far and should improve intermediate distance better than monofocal lens do.

Device: Accommodating Tetraflex HD lens, Lenstec inc.

Monofocal IOL group

ACTIVE COMPARATOR

Patients implanted during cataract or refractive surgery with standard monofocal lens, which allowed to see for far but patients do not experiences optical phenomena or low contrast sensitivity.

Device: Monofocal lens, Softec HD

Interventions

Trifocal lens AT LISA TRI, ZeissDEVICE

lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design

Trifocal IOL group
Accommodating Tetraflex HD lens, Lenstec inc.DEVICE

lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design

Accommodating IOL group
Monofocal lens, Softec HDDEVICE

lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design

Monofocal IOL group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • phacoemulsification with one of the 3 types of lens implantation before 36 to 48months
  • no other ocular pathology affecting visual acuity
  • able to maintain follow up visit

You may not qualify if:

  • corneal opacities or irregularities
  • amblyopia
  • glaucoma with change in visual fields
  • any other type of ocular surgery than phacoemulsification with primary lens implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eye Center Prague

Prague, Czech Republic, 11000, Czechia

RECRUITING

Eye Center Sokolik

Trenčín, 91101, Slovakia

RECRUITING

Study Officials

  • Andrea Janekova, MD

    Faculty Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Janekova, MD

CONTACT

+420775727002janekovaandrea@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 13, 2021

Study Start

September 1, 2020

Primary Completion

February 1, 2022

Study Completion

June 1, 2022

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

CZ(1)SL(1)