An interventional study of Evolux and Tecnis Eyhance 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 2024-04-04.
Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science
Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.
In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.
To achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.
A newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.
The aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 35 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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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.
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 Enova IOL during cataract surgery
Device: Evolux
Patient will receive the Tecnis Ehance IOL during cataract surgery
Device: Tecnis Eyhance
Evolux, enhanced monofocal IOL
Tecnis Eyhance, enhanced monofocal IOL
Monocular intermediate visual acuity
Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts
Time frame: 24 months
Monocular distance visual acuity
Monocular distance visual acuity at 4 meters will be measured using ETDRS charts
Time frame: 24 months
Monocular near visual acuity
Monocular near visual acuity at 40 cm will be measured using ETDRS charts
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2025, 24 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 24 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
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Vienna Institute for Research in Ocular Surgery