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Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality

Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06624826
Enrollment
60
Registered
2024-10-03
Start date
2024-10-01
Completion date
2026-09-30
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality

Detailed description

With an expanding market of different types of intraocular lenses (IOL), spectacle independence is a rising aim in modern cataract surgery. The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach. Although bilateral monofocal IOL implantation, aiming for emmetropia, leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result. The option commonly used to achieve spectacle independence at intermediate distance (e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. These IOLs have an extended far focus area which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The spectrum ranges from small aperture design, bioanalogic design, to diffractive and non-diffractive optics. The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia. A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. To increase spectacle independence for these patients, IOLs may be used in a monovision modality, with an offset of up to 1.5dpt. This method showed good results in the literature so far for monofocal and multifocal intraocular lenses. Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set for emmetropia or monovision. 120 eyes of 60 patients will be included into this study. Patients will be either randomized in the emmetropia or the monovision group Follow-up visits will be 1 week after each surgery and 3 months post-surgically. During these visits, the clinical variables to be assessed will be visual acuity, stereopsis, contrast sensitivity, and binocular defocus curves.

Interventions

DEVICEEmmetropic modality

PureSee IOL, emmetropic modality

DEVICEMonovision modality

PureSee IOL, monovision modality

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
No

Inclusion criteria

* Age-related bilateral cataract * Age 21 or older * Visual acuity > 0.05 * Axial length: 21.00-27.00mm * 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) * 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)

Design outcomes

Primary

MeasureTime frameDescription
Corrected and uncorrected binocular visual acuity for near distance12 monthsCorrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts

Secondary

MeasureTime frameDescription
Corrected and uncorrected binocular visual acuity for distance12 monthsCorrected and uncorrected binocular visual acuity for distance will be assessed at 4 m using ETDRS charts
Corrected and uncorrected binocular visual acuity for intermediate distance12 monthsCorrected and uncorrected binocular visual acuity for intermediate distance will be assessed at 66 cm using ETDRS charts
Contrast sensitivity12 monthsContrast sensitivity will be tested using the Optec Vision tester under mesopic and photopic conditions with and without an additional glare source
Subjective quality of vision12 monthsSubjective quality of vision will be assessed using a questionnaire

Countries

Austria

Contacts

Primary ContactJohannes Zeilinger, MD
office@viros.at01 91021 57564
Backup ContactNatascha Bayer, MSc
office@viros.at01 91021 57564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026