Status:
ACTIVE_NOT_RECRUITING
Visual Performance of Patients Implanted With a Multifocal IOL
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Cataract
Refractive Lens Exchange
Eligibility:
All Genders
18+ years
Phase:
NA
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 questio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06111222
Start Date
October 31 2023
End Date
October 1 2025
Last Update
July 18 2025
Active Locations (3)
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1
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
2
PVK Precise Vision GmbH
Rheine, Germany, 48429
3
Ofatlivist Alicante
Alicante, Spain, 03001