Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Add EDOF IOL, EDOF IOL.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 21 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
Overview
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.
Interventions
- Device Low-Add EDOF IOL
Acunex Vario AN6V - Device EDOF IOL
PureSee EDOF IOL
Primary outcome measures
- Distance corrected visual acuity for intermediate distance [Time frame: 6 months]
Secondary outcome measures (7)
- Uncorrected visual acuity for intermediate distance [Time frame: 6 months]
- Uncorrected and distance corrected visual acuity for far distance [Time frame: 6 months]
- Uncorrected and distance corrected visual acuity for near distance [Time frame: 6 months]
- Defocus curve assessment [Time frame: 6 months]
- Halometry [Time frame: 6 months]
- Contrast sensitivity [Time frame: 6 months]
- Subjective rating of dysphotopsia [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna
Identifiers
NCT: NCT06607848 · Vario vs. PureSee