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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intraocular Lens

Intervention / Treatment
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* Device: Trifocal lens AT LISA TRI, Zeiss
* Device: Accommodating Tetraflex HD lens, Lenstec inc.
* Device: Monofocal lens, Softec HD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trifocal IOL group<br>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<br>* lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design<br>|
| Active Comparator: Accommodating IOL group<br>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.<br>* lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design<br>|
| Active Comparator: Monofocal IOL group<br>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<br>* lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trifocal lens, accommodating lens, monofocal lens, optical phenomena, glare