Prospective monocentric PMCF study after bilateral, combined implantation of a glistening-free, hydrophobic, rotationally asymmetric EDOF and multifocal intraocular lens based on the blended vision principle evaluating visual acuity and patient satisfactio
- Conditions
- H28Cataract and other disorders of lens in diseases classified elsewhere
- Registration Number
- DRKS00026782
- Lead Sponsor
- Teleon Surgical B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
• Patient age > 40 years
• Bilateral cataract / bilateral intervention
• Expected post-operative corneal astigmatism = 0.75 D
• Planned implantation in the capsular bag
• photopic pupil size between 3 and 6 mm
• Pupil decentering <0.8 mm (center shift)
• Contact lens wear within the last 2 weeks before screening
• Presence of a written declaration of informed consent from the patient
• Amblyopia,
• Strabismus
• Pregnancy
• Zonulolysis
• Keratoplasty
• Irregular Corneal Astigmatism
• Previous corneal refractive interventions or surgical glaucoma interventions
• Diseases other than cataract, which may result in postoperative, monocular best-corrected distance vision <0.63 (decimal visual acuity)
• Intraoperative complications
• The patient's current active participation in another clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Binocular uncorrected visual acuity for near vision using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts. Both eyes are examined on each patient. The visual acuity data are evaluated preoperatively and 1-7 days, 1, 6 and 12-24 months after cataract surgery.
- Secondary Outcome Measures
Name Time Method