h25 H26
Conditions
Interventions
Group 1: The artificial lenses (Tecnis® Multifocal 1-Piece IOL) will be implanted into both eyes of the patients after having removed the cataract.
Sponsors
AMO
Debbie Trentacost
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Minimum 18 years of age • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned • Potential for postoperative best-corrected visual acuity of 20/25 or better • Preoperative corneal astigmatism of 1.0 D or less with no irregular astigmatism • Clear intraocular media, other than cataract • Availability, willingness and sufficient cognitive awareness to comply with examination procedures • Signed informed consent to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Exclusion criteria
Exclusion criteria: • Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes • Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects • Use of systemic or ocular medications that may affect vision • Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery • Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable. • Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes • Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. monocular uncorrected distance visual acuity with ETDRS reading charts, 1 and 3 months after binocular implantation 2. monocular distance-corrected near vision with ETDRS reading charts, 1 and 3 months after binocular implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. binocular corrected distance and distance corrected near visual acuity with ETDRS reading charts, 1 and 3 months after binocular implantation 2. depth of field with ETDRS reading charts and set trail fram glasses at 1 and 3 months after binocular implantation 3. questionnaire on patient satisfaction 3 months after binocular implantation 4. complications and side effects at each postoperative examination | — |
Countries
Belgium, Germany, Portugal
Contacts
Public ContactRoland Pohl
AMO Vertreter für Europa
Outcome results
None listed