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

Intraocular Lens Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041881
• Other study ID #: TRIMACO
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2021
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Andrea Janekova, MD
• Phone: +420775727002
• Email: janekovaandrea[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Lens

Intervention

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

Locations

Country	Name	City	State
Czechia	Eye Center Prague	Prague	Czech Republic
Slovakia	Eye Center Sokolik	Trencín

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Countries where clinical trial is conducted

Czechia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of visual acuity for distance between groups	uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA)	36-48 months after surgery
Primary	Comparison of visual acuity for intermediate between groups	Uncorrected intermediate visual acuity (UIVA) Distance corrected intermediate visual acuity (DCIVA)	36-48 months after surgery
Primary	Comparison of near visual acuity between group 1 (trifocal lens) and group 2 (accommodating lens)	uncorrected near visual acuity (UNVA)	36-48 months after surgery
Primary	Contrast sensitivity comparison between groups	Photopic contrast sensitivity with glare Mesopic contrast sensitivity with glare Mesopic contrast sensitivity without glare	36-48 months after surgery
Primary	Incidence of posterior capsule opacification (PCO)	Incidence of PCO and needed Nd YAG capsulotomy treatment in each group	36-48 months after surgery