NCT05041881

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Faculty Hospital Kralovske Vinohrady · Other Government
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intraocular Lens

Interventions

Type	Name	Description
DEVICE	Trifocal lens AT LISA TRI, Zeiss	lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design
DEVICE	Accommodating Tetraflex HD lens, Lenstec inc.	lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
DEVICE	Monofocal lens, Softec HD	lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-02-01
• Completion: 2022-06-01
• First posted: 2021-09-13
• Last updated: 2021-10-01

Locations

2 sites across 2 countries: Czechia, Slovakia