Cataracts Eye Diseases Cataracts
Conditions
Interventions
Participants are allocated to one of four different arms (SN6AD1 group, SN6AD3 group, FIL611PV group and FIL618 group) by block randomization. All participants receive a complete ophthalmological preo
Sponsors
Institute of Ophthalmology
San Luigi Gonzaga University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 50 years 2. Bilateral cataract 3. Maximum regular corneal astigmatism of 1.0 D
Exclusion criteria
Exclusion criteria: 1. Optical means opacities different from cataract 2. Age-related macular degeneration 3. Previous history of ocular surgery 4. Irregular corneal astigmatism 5. Amblyopy 6. Concurrent neuro-muscular diseases (i.e. cerebral ictus, myasthenia) 7. Uncontrolled open/close-angle glaucoma 8. Severe ocular complications related to diabetes (i.e. retinopathy, macular edema, vitreal hemorrhage) 9. Intra/postoperative complications 10. Pupil diameter = 5,2 mm in mesopic lighting conditions measured with a slit lamp-based cobalt blue light method
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. Additional correction (diopters), in order to achieve best-corrected binocular visual acuity at intermediate and near distances, assessed with trial lenses during visual acuity examination with Jaeger eye chart for both eyes at the preoperative time and 6 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of visual disturbances (glare, difficulties in night vision, difficulties in colour perception, difficulties in depth perception, halos, distorted close-up vision, distorted vision for far distances, obscured close-up vision, obscured vision for far distances, doubled vision) is assessed by patient questionnaires with scores from 0 (for absence of disturbances) to 5 (for maximal difficulty) designed for the purpose of this study at six months after surgery (follow-up visit) 2. Spectacle dependence rate at intermediate and close-up distances is assessed by a patient questionnaire with scores from 0 (total independence) to 5 (for maximal dependence) designed for the purpose of this study at six months after surgery (follow-up visit) 3. Global visual satisfaction is assessed by a patient questionnaire with scores from 0 (totally unsatisfied) to 5 (totally satisfied) designed for the purpose of this study at six months after surgery (follow-up visit) 4. Difficulties in everyday activities is assessed using a patient questionnaire with scores from 0 (no difficulties) to 5 (for maximal difficulty) designed for the purpose of this study at six months after surgery (follow-up visit) FIL618 IOL Group only (measured in each eye): 1. Surgical capsulorhexis diameter is measured using a mm caliper applied on the excised portion of the capsular bag at the end of the capsulorhexis procedure (in course of surgical intervention) 2. Ocular axial length is measured using IOL Master and/or Ultrasound contact biometry at pre-surgical evaluation 3. Preoperative visual defect measured with Automatic refractometry at pre-surgical evaluation | — |
Countries
Italy
Outcome results
None listed