An interventional study of Emmetropic modality and Monovision modality in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Treatment
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 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.
Patient will receive the PureSee IOL with an emmetropic modality
Device: Emmetropic modality
Patient will receive the PureSee IOL in a monovision modality
Device: Monovision modality
PureSee IOL, emmetropic modality
PureSee IOL, monovision modality
Corrected and uncorrected binocular visual acuity for near distance
Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts
Time frame: 12 months
Corrected and uncorrected binocular visual acuity for distance
Corrected and uncorrected binocular visual acuity for distance will be assessed at 4 m using ETDRS charts
Time frame: 12 months
Corrected and uncorrected binocular visual acuity for intermediate distance
Corrected and uncorrected binocular visual acuity for intermediate distance will be assessed at 66 cm using ETDRS charts
Time frame: 12 months
Contrast sensitivity
Contrast sensitivity will be tested using the Optec Vision tester under mesopic and photopic conditions with and without an additional glare source
Time frame: 12 months
Subjective quality of vision
Subjective quality of vision will be assessed using a questionnaire
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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Prim. Prof. Dr. Oliver Findl, MBA