An interventional study of Low-Add EDOF IOL and EDOF IOL in Cataract, sponsored by Vienna Institute for Research in Ocular Surgery. Recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Treatment
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 40 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the Acunex IOL during cataract surgery
Device: Low-Add EDOF IOL
Patients will receive the PureSee IOL during cataract surgery
Device: EDOF IOL
Acunex Vario AN6V
PureSee EDOF IOL
Distance corrected visual acuity for intermediate distance
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Time frame: 6 months
Uncorrected visual acuity for intermediate distance
Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Time frame: 6 months
Uncorrected and distance corrected visual acuity for far distance
Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts
Time frame: 6 months
Uncorrected and distance corrected visual acuity for near distance
Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts
Time frame: 6 months
Defocus curve assessment
Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart
Time frame: 6 months
Halometry
Potential halos will be assessed using the Aston Halometer App provided on a Tablet at 2 m
Time frame: 6 months
Contrast sensitivity
Contrast sensitivity will be tested using the Optec device
Time frame: 6 months
Subjective rating of dysphotopsia
Dysphotopsia will be subjectively rated by the patients using a questionnaire and a visual analogue scale
Time frame: 6 months
Plan to share: No
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Vienna Institute for Research in Ocular Surgery