Visual Performance of Patients Implanted with a Multifocal IOL
- Conditions
- Refractive Lens ExchangeCataract
- Interventions
- Device: HECATE
- Registration Number
- NCT06111222
- Lead Sponsor
- Carl Zeiss Meditec AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bilateral implantation of investigational device HECATE Bilateral implantation of investigational device
- Primary Outcome Measures
Name Time Method Mean monocular best-corrected distance visual acuity (CDVA) Three (3) Months The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
- Secondary Outcome Measures
Name Time Method Refractive Predictability / Manifest Refraction and Prediction Error Twelve (12) Months Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability
Trial Locations
- Locations (6)
PVK Precise Vision GmbH
🇩🇪Rheine, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Dr. Pedro Tañá Rivero
🇪🇸Alicante, Spain
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
PVK Precise Vision GmbH
🇩🇪Rheine, Germany
Dr. Pedro Tañá Rivero
🇪🇸Alicante, Spain