Cataract surgery (phacoemulsification) Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Bilateral cataract 2. Age >50 years 3. Regular corneal astigmatism, <1.00 D 4. K angle =1 mm
Exclusion criteria
Exclusion criteria: 1. Patient with optical means opacities other from cataract 2. Age-related macular degeneration 3. Previous history of ocular surgery 4. Irregular corneal astigmatism 5. Amblyopia 6. Concurrent neurologic or neuromuscular diseases (cerebral ictus, myasthenia, etc.) 7. Uncontrolled open/close-angle glaucoma 8. Severe ocular complications related to diabetes (retinopathy, macular oedema, vitreal hemorrhage, etc.) 9. Patients with operative or postoperative complications 10. Patients with a pupil diameter of = 5,2 mm in mesopic lighting conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Postoperative uncorrected and best-corrected visual acuity for far distances is assessed with LogMar and ETDRS charts for each eye at 1 day, 7 days, 1 month, 3 months and 6 months 2. Postoperative uncorrected and best-corrected visual acuity for intermediate distances (60 cm) is assessed using the Jeager eye chart for each eye at 1 day, 7 days, 1 month, 3 months and 6 months 3. Postoperative uncorrected and best-corrected visual acuity for near distances (33cm) is assessed using the Jaeger eye chart for each eye at 1 day, 7 days, 1 month, 3 months and 6 months 4. Postoperative binocular uncorrected visual acuity for far (4 m), intermediate (60 cm) and near (33 cm) distances at 1 month, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of visual disturbances was assessed with specific questionnaires with scores from 0 (for absence of disturbances) to 5 (for maximal difficulty) at 1 month, 3 months and 6 months after sugery 2. Spectacle dependence rate at far, intermediate and near visual distances was assessed with specifict questionnaires with scores from 0 (total independence) to 5 (for maximal dependence) at 1 month, 3 months and 6 months after sugery 3. Global visual satisfaction was assessed with specifict questionnaires with scores from 0 (absolutely not satisfied) and 10 (fully satisfied) at 1 month, 3 months and 6 months after sugery 4. Difficulties in everyday activities was assessed with specifict questionnaires with scores from 0 (total ease) to 5 (maximal difficulty) at 1 month, 3 months and 6 months after sugery | — |
Countries
Italy