NCT06607848

Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Vienna Institute for Research in Ocular Surgery · Academic / Other
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Not accepted

Summary

Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.

Detailed description

Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome. Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses. The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study. The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo\&glare, optical coherence tomography, fundus examination, aberrometry and keratometry. The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Low-Add EDOF IOL	Acunex Vario AN6V
DEVICE	EDOF IOL	PureSee EDOF IOL

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2024-09-23
• Last updated: 2024-09-23

Locations

1 site across 1 country: Austria