Cataract, Presbyopia
Conditions
Keywords
Refractive lens exchange (RLE) or cataract surgery
Brief summary
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
Detailed description
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
Interventions
DEVICEIOL MINI WELL READY
IOL MINI WELL READY
Sponsors
Opera CRO, a TIGERMED Group Company
SIFI SpA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any gender and age above 18 years. * Refractive lens exchange (RLE) or cataract surgery. * Healthy corneas, not treated surgically. * Patients willing to have surgery in both eyes in a short period of time (within 2 weeks). * Patients request to receive the IOL MINI WELL READY implant
Exclusion criteria
* Previous corneal surgery (i.e. pterygium, refractive surgery). * Eye diseases determining a probable postoperative visual acuity \< 20/40. * Pseudoexfoliation. * Abnormal pupil size and position. * Use of contact lens 30 days before the preoperative visit. * Corneal warpage. * Predicted postoperative corneal astigmatism higher than 1 D.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UDVA (Uncorrected Distance Visual Acuity) | 30 days | Visual acuity mesurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE). | 4 months | Safety assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity | 4 months | Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (''vistech) |
| Halos and Glare evaluation | 4 months | Onset of halos Onset of glare during night vision |
| Defocus Curve | 4 months | Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions. |
| Reading Performance | 4 months | Reading Performance tested with Radner Reading Chart - Precision Vision: The test will be performed from the largest to the smallest size of letters in two sessions: * Binocular, without the correction for distance, at 40 cm * Binocular, with the correction for distance, at 40 cm |
| Visual Acuity Evaluation | 4 months | Corrected Distance Visual Acuity (CDVA) |
Countries
Germany
Outcome results
None listed