Long-term Comparative Analysis of Visual Outcomes With 3 Intraocular Lenses: Monofocal, Trifocal and Accommodating

Sponsor
Faculty Hospital Kralovske Vinohrady (Other)
Overall Status
Recruiting
CT.gov ID
NCT05041881
Collaborator
(none)
40
Enrollment
2
Locations
3
Arms
21
Anticipated Duration (Months)
20
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Trifocal lens AT LISA TRI, Zeiss
  • Device: Accommodating Tetraflex HD lens, Lenstec inc.
  • Device: Monofocal lens, Softec HD
N/A

Detailed Description

The goal of cataract surgery is to remove lens opacity and restore vision. Nowadays most of the patients wanted to be spectacle independent. The desire of visual acuity for all distances increases the popularity of multifocal and trifocal lenses. As these type of lenses are mostly based on diffractive structure, there could be occurrence of unwanted optical phenomena and lower contrast sensitivity. The effort is to produce intraocular lens (IOL) with good vision for all distances without these unwanted effects. Increasing daily task for intermediate distance led to the new category of IOLs- EDOF( extended depth of focus) IOLS, which are based mostly on diffractive profiles too, but should have less optical phenomena occurrence. To completely remove glare, halo and retain standard good contrast sensitivity enhance monofocal lenses were invented, mostly based on spherical aberrations, but not achieving as good intermediate vision as multifocal or EDOF lenses do. Accommodating lenses should provide better intermediate distance without unwanted optical effects on vision.

This study is retro-prospective, comparing 3 different lenses in long-term period. First group includes patients with trifocal lens allowing patients to see for all distances, second group includes patients with implanted accommodating lens which allows good distance and better intermediate distance than monofocal. Third group include patients with standard monofocal lens. Preoperative data were collected retrospectively and one prospective visit was scheduled in period 36- 48 months after the surgery. Study is conducted in 2 eye centers- one in Slovakia Trenčín, one in Prague, Czech Republic. The study was approved by the Ethic committee of faculty hospital Hradec Kralove (202103 P08). and will enrolled up 40 patients in each category.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocaleach group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-term Comparative Analysis of Visual Outcomes and Patients Satisfaction With 3 Intraocular Lenses: Trifocal, Accommodating and Monofocal
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Trifocal IOL group

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

Active Comparator: Accommodating IOL group

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

Active Comparator: Monofocal IOL group

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of visual acuity for distance between groups [36-48 months after surgery]

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

  2. Comparison of visual acuity for intermediate between groups [36-48 months after surgery]

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

  3. Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens) [36-48 months after surgery]

    uncorrected near visual acuity (UNVA)

  4. Contrast sensitivity comparison between groups [36-48 months after surgery]

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

  5. Incidence of posterior capsule opacification (PCO) [36-48 months after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • corneal opacities or irregularities

  • amblyopia

  • glaucoma with change in visual fields

  • any other type of ocular surgery than phacoemulsification with primary lens implantation

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Center PraguePragueCzech RepublicCzechia11000
2Eye Center SokolikTrenčínSlovakia91101

Sponsors and Collaborators

  • Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: Andrea Janekova, MD, Faculty Hospital Kralovske Vinohrady

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Janekova, Principal Investigator, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier:
NCT05041881
Other Study ID Numbers:
  • TRIMACO
First Posted:
Sep 13, 2021
Last Update Posted:
Oct 1, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Janekova, Principal Investigator, Faculty Hospital Kralovske Vinohrady

Study Results

No Results Posted as of Oct 1, 2021