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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifocal lens AT LISA TRI, Zeiss | Device | lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Janekova, MD | Contact | +420775727002 | janekovaandrea@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Janekova, MD | Faculty Hospital Kralovske Vinohrady | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center Prague | Recruiting | Prague | Czech Republic | 11000 | Czechia |
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each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
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| Accommodating Tetraflex HD lens, Lenstec inc. | Device | lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design |
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| Monofocal lens, Softec HD | Device | lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design |
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| Eye Center Sokolik | Recruiting | Trenčín | 91101 | Slovakia |
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