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

Not Applicable

Recruiting

• Conditions: Cataract
• Interventions: Device: Low-Add EDOF IOL; Device: EDOF IOL

• Registration Number: NCT06607848
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

Brief 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.

Study Timeline

• Study Start: 2024-07-29
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

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

Inclusion Criteria

• Age-related bilateral cataract
• Age 21 or older
• Visual acuity > 0.05
• For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
• Written informed consent prior to surgery

Exclusion Criteria

• Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
• Corneal decompensation or corneal endothelial cell insufficiency
• Irregular astigmatism on corneal tomography
• Pronounced dry eye disease
• Previous ocular surgery or trauma
• Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acunex Vario AN6V	Low-Add EDOF IOL	Patients will receive the Acunex IOL during cataract surgery
PureSee	EDOF IOL	Patients will receive the PureSee IOL during cataract surgery

Primary Outcome Measures

Name	Time	Method
Distance corrected visual acuity for intermediate distance	6 months	Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts

Secondary Outcome Measures

Name	Time	Method
Uncorrected visual acuity for intermediate distance	6 months	Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Uncorrected and distance corrected visual acuity for far distance	6 months	Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts
Uncorrected and distance corrected visual acuity for near distance	6 months	Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts
Defocus curve assessment	6 months	Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart
Halometry	6 months	Potential halos will be assessed using the Aston Halometer App provided on a Tablet at 2 m
Contrast sensitivity	6 months	Contrast sensitivity will be tested using the Optec device
Subjective rating of dysphotopsia	6 months	Dysphotopsia will be subjectively rated by the patients using a questionnaire and a visual analogue scale

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna; 🇦🇹 Vienna, Austria