Intraocular Lens
Conditions
Keywords
trifocal lens, accommodating lens, monofocal lens, optical phenomena, glare
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.
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.
Interventions
DEVICETrifocal lens AT LISA TRI, Zeiss
lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design
DEVICEAccommodating Tetraflex HD lens, Lenstec inc.
lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
DEVICEMonofocal lens, Softec HD
lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
Sponsors
Faculty Hospital Kralovske Vinohrady
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of visual acuity for distance between groups | 36-48 months after surgery | uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA) |
| Comparison of visual acuity for intermediate between groups | 36-48 months after surgery | Uncorrected intermediate visual acuity (UIVA) Distance corrected intermediate visual acuity (DCIVA) |
| 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) |
| 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 |
| Incidence of posterior capsule opacification (PCO) | 36-48 months after surgery | Incidence of PCO and needed Nd YAG capsulotomy treatment in each group |
Countries
Czechia, Slovakia
Contacts
Primary ContactAndrea Janekova, MD
Outcome results
None listed