H28
Conditions
Interventions
Group 1: Patients diagnosed with bilateral cataract and meets the in- and exclusion criteria are included in the study after detailed written and verbal explanations, after signing the declaration of
Sponsors
Teleon Surgical B.V.
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - Uncorrected distant visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA, 66 cm), each monocular and binocular, uncorrected near visual acuity (UNVA, 40 cm) monocular using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts preoperatively and 1-7 days, 1 and 6 months postoperatively - Corrected distance visual acuity (CDVA), corrected intermediate visual acuity (DCIVA, 66 cm), corrected near visual acuity (DCNVA, 40 cm) each monocular and binocular, using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts preoperatively and 1, 6 and 12-24 months postoperatively - Subjective refraction using corrective glasses or phoropters preoperatively and 1, 6 und 12-24 months postoperatively - Defocus curve monocular and binocular, using ETDRS (Early Treatment of Diabethic Retinopathia Study) charts after 6 and 12-24 months postoperatively - Monocular contrast sensitivity measurements using Pelli Robson tables after 6 and 12-24 months postoperatively - Patient satisfaction using a questionnaire on optical quality after 6 and 12-24 months postoperatively | — |
Countries
Germany
Contacts
Public ContactChristoph Thiemann
Augentagesklinik Spreebogen
Outcome results
None listed