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

Not Applicable

• Conditions: Intraocular Lens
• Interventions: Device: Accommodating Tetraflex HD lens, Lenstec inc.; Device: Monofocal lens, Softec HD; Device: Trifocal lens AT LISA TRI, Zeiss

• Registration Number: NCT05041881
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accommodating IOL group	Accommodating Tetraflex HD lens, Lenstec inc.	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.
Monofocal IOL group	Monofocal lens, Softec HD	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.
Trifocal IOL group	Trifocal lens AT LISA TRI, Zeiss	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

Primary Outcome Measures

Name	Time	Method
Comparison of visual acuity for distance between groups	36-48 months after surgery	uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA)
Incidence of posterior capsule opacification (PCO)	36-48 months after surgery	Incidence of PCO and needed Nd YAG capsulotomy treatment in each group
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
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)

Trial Locations

Locations (2)

Eye Center Prague; 🇨🇿 Prague, Czech Republic, Czechia

Eye Center Sokolik; 🇸🇰 Trenčín, Slovakia