Clinical trial NCT05041881: Long-term Comparative Analysis of Visual Outcomes With 3 Intraocular Lenses: Monofocal, Trifocal and Accommodating
Official title: Long-term Comparative Analysis of Visual Outcomes and Patients Satisfaction With 3 Intraocular Lenses: Trifocal, Accommodating and Monofocal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Lens
Keywords: trifocal lens
accommodating lens
monofocal lens
optical phenomena
glare
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2021-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: each group consist of patient receiving one type of intraocular lens- trifocal, accommodating or monofocal
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of visual acuity for distance between groups
timeFrame: 36-48 months after surgery
measure: Comparison of visual acuity for intermediate between groups
timeFrame: 36-48 months after surgery
measure: Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens)
timeFrame: 36-48 months after surgery
measure: Contrast sensitivity comparison between groups
timeFrame: 36-48 months after surgery
measure: Incidence of posterior capsule opacification (PCO)
timeFrame: 36-48 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Eye Center Prague
state: Czech Republic
city: Trenčín
country: Slovakia
facility: Eye Center Sokolik
Study officials:
affiliation: Faculty Hospital Kralovske Vinohrady
name: Andrea Janekova, MD
role: PRINCIPAL_INVESTIGATOR
References: