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

Faculty Hospital Kralovske Vinohrady

Status: Unknown

Conditions: Intraocular Lens

Treatments: Device: Trifocal lens AT LISA TRI, Zeiss; Device: Accommodating Tetraflex HD lens, Lenstec inc.; Device: Monofocal lens, Softec HD

Study type: Interventional

Funder types: Other

Identifiers

NCT05041881

TRIMACO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Trifocal IOL group

Active Comparator group

Description:

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

Treatment:

Device: Trifocal lens AT LISA TRI, Zeiss

Accommodating IOL group

Active Comparator group

Description:

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.

Treatment:

Device: Accommodating Tetraflex HD lens, Lenstec inc.

Monofocal IOL group

Active Comparator group

Description:

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.

Treatment:

Device: Monofocal lens, Softec HD