EDoF IOLs vs Monofocal IOL

Study Overview
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Brief Summary
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prospective, comparative (3 arms), randomized, multicentric clinical trial

Official Title
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Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: EDoF1
* Device: Monofocal
* Device: EDoF2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent; Patients of any gender, aged 50 to 80 years; Assured follow-up examinations; clinically significant bilateral cataract; Exclusion Criteria: Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial; Patients whose freedom is impaired by administrative or legal order; Current participation in another drug or device investigation; Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.) Pseudoexfoliations syndrome Pathologic miosis or Pharmacotherapy with miotic agent Keratoconus Chronic or recurrent uveitis Diabetic retinopathy Uncontrolled glaucoma and or IOP>24mmHg Choroidal hemorrhage, All kind of infections (acute ocular disease, external/internal infection, systemic infection) Traumatic cataract Aniridia Microphthalmia Amblyopia Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders) Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up Previous intraocular and corneal surgery Expected postop. astigmatism greater than 1 D Any type of corneal disorder Systemic or ocular pharmacotherapy, which can impact the visual acuity, Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus) Dementia pregnancy or lactation period for female patients

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EDoF1<br> | Device: Monofocal<br>* Monofocal IOL<br>Device: EDoF2<br>* Comparison EDoF2 IOL<br>|
| Active Comparator: Monofocal<br> | Device: EDoF1<br>* extended depth of focus IOL - EDoF1<br>Device: EDoF2<br>* Comparison EDoF2 IOL<br>|
| Active Comparator: EDoF2<br> | Device: EDoF1<br>* extended depth of focus IOL - EDoF1<br>Device: Monofocal<br>* Monofocal IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus curve measurement |  | 1 month |