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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Lens
• Intervention / Treatment: Device: Trifocal lens AT LISA TRI, Zeiss; Device: Accommodating Tetraflex HD lens, Lenstec inc.; Device: Monofocal lens, Softec HD

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia, 11000
      • Recruiting
      • Eye Center Prague
      • Contact: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com
• Slovakia
  • Trenčín, Slovakia, 91101
    • Recruiting
    • Eye Center Sokolik
    • Contact: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: glare; trifocal lens; monofocal lens; accommodating lens; optical phenomena
• Other Study ID Numbers: TRIMACO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No