Cataract, Lens Opacities, Presbyopia
Conditions
Keywords
Intraocular lens, Trifocal
Brief summary
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
Detailed description
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted. Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel. Main objectives: 1. Functional results (refraction and visual acuity results) Secondary goals: 2. Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation) 3. Subjective patient satisfaction 4. Visual quality (e.g. scattered light, contrast vision, spherical aberrations) 5. Stability of the results achieved postoperatively
Interventions
DEVICEPOD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study procedure guidelines Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included: Retrospective: Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively Prospective: 2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Bilateral implantation of one of the following IOL models * Alcon PanOptix (TFNT00) * PhysIOL FineVision (POD F) * PhysIOL FineVision (POD F GF) * Uneventful cataract surgery with first clinical outcomes in the expected range * Patient included in Premium IOL study protocol by signed informed consent
Exclusion criteria
* Age of patient \<45 years * Irregular astigmatism * Postoperative manifested astigmatism of \>1.0 D * Difficulty for cooperation (distance from their home, general health condition) * Clinically significant glaucoma * Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy * Patients with keratoconus or keratectasia * Any ocular comorbidity having a significant effect on the postoperative clinical outcomes * History of ocular trauma or prior ocular surgery including refractive procedures * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome) * Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * AMD * Intraoperative complications like capsular rupture etc. * Patients who do not give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Best corrected distance visual acuity (5 m) | Postoperative Day 75-105 (3 months) | CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014. |
Countries
Germany
Outcome results
None listed