Clinical trial NCT06111222: Visual Performance of Patients Implanted With a Multifocal IOL
Official title: Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Refractive Lens Exchange
Keywords: cataract
multifocal IOL
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean monocular best-corrected distance visual acuity (CDVA)
timeFrame: Three (3) Months
Secondary outcomes:
measure: Refractive Predictability / Manifest Refraction and Prediction Error
timeFrame: Twelve (12) Months
Other outcomes:
measure: Uncorrected Visual Acuities
timeFrame: Twelve (12) Months
measure: Corrected Distance Visual Acuities
timeFrame: Twelve (12) Months
measure: Corrected Intermediate and Near Visual Acuities
timeFrame: Twelve (12) Months
measure: Refractive predictability
timeFrame: Twelve (12) Months
measure: Patient Reported Outcome Measures (PROMs)
timeFrame: Three (3) Months
measure: Postoperative use of spectacles
timeFrame: Twelve (12) Months
measure: Defocus Curves
timeFrame: Twelve (12) Months
measure: Binocular Contrast Sensitivity
timeFrame: Twelve (12) Months
measure: Posterior Capsule Opacification (PCO)
timeFrame: Twelve (12) Months
measure: Nd:YAG rate
timeFrame: Twelve (12) Months
measure: Optimization of CZM IOL calculation tools
timeFrame: Twelve (12) Months
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Rheine
country: Germany
facility: PVK Precise Vision GmbH
city: Alicante
country: Spain
facility: Dr. Pedro Tañá Rivero
Study officials:
References: