Visual Performance of Patients Implanted With a Multifocal IOL

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.

Official Title
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Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens

Conditions
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Cataract, Refractive Lens Exchange

Intervention / Treatment
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* Device: HECATE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older; Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D No visual acuity limiting pathologies other than cataract; Corneal Astigmatism of <1.0 D; Availability, willingness, and sufficient cognitive awareness to comply with examination procedures; Written informed consent for participation in the study and data protection. Exclusion Criteria: Corneal Astigmatism of ≥1.0 D; Difficulty for cooperation (distance from their home, general health conditions); History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.); Visual field loss which has an impact on visual acuity; Use of systemic or ocular medication that might affect vision; Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus; Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions); Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome); Cataract grades of 4, 5 or 6 on the LOCSIII scale ; Surgeries with incision size of ≥2.75mm ; Immediate Sequential Bilateral Cataract Surgery ; Concurrent participation in another device investigation; Usage of contact lenses during participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bilateral implantation of investigational device<br>Bilateral implantation of investigational device | Device: HECATE<br>* The device is CE-approved. The device is a posterior chamber multifocal intraocular lens (IOL) indicated for aphakia after surgical extraction of the cataractous natural lens. The device is also indicated for non-cataractous, presbyopic patients (PRELEX) who seek greater independence from glasses for intermediate and/or near distances. It is an aspheric (aberration-neutral) IOL made of hydrophobic acrylic material, coated with heparin with modified C-loop haptics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean monocular best-corrected distance visual acuity (CDVA) | The objective is to evaluate Corrected Distance Visual Acuity (CDVA) | Three (3) Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive Predictability / Manifest Refraction and Prediction Error | Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability | Twelve (12) Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, multifocal IOL