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

Vienna Institute for Research in Ocular Surgery

Status: Enrolling

Conditions: Cataract

Treatments: Device: Low-Add EDOF IOL; Device: EDOF IOL

Study type: Interventional

Funder types: Other

Identifiers

NCT06607848

Vario vs. PureSee

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Acunex Vario AN6V

Experimental group

Description:

Patients will receive the Acunex IOL during cataract surgery

Treatment:

Device: Low-Add EDOF IOL

PureSee

Experimental group

Description:

Patients will receive the PureSee IOL during cataract surgery

Treatment:

Device: EDOF IOL

Sponsor of this trial

Lead Sponsor

Vienna Institute for Research in Ocular Surgery