Cataract Senile
Conditions
Keywords
IOL, Cataract
Brief summary
Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)
Detailed description
Extended depth of Focus intraocular lens versus a monofocal intraocular lens
Interventions
DEVICEEDF
Extended depth of focus
DEVICEMonofocal IOL
Monofocal
Sponsors
Carl Zeiss Meditec AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of any gender, aged 18 years or older 2. Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement 3. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) 4. Calculated lens power within the available range 5. Clear intraocular media other than cataract 6. Patient is willing and capable of providing informed consent 7. Patient is willing and capable of complying with visits and procedures as defined by this protocol
Exclusion criteria
1. Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal) 2. Endothelial cell count of less than 2000/mm2 3. Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc. 4. Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study 5. Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia 6. Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.) 7. Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 8. Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study 9. Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk 10. Clinically significant gonioscopic abnormalities 11. Amblyopia, strabismus, single eye status 12. Rubella, congenital, traumatic or complicated cataracts 13. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis 14. Microphthalmos or macrophthalmos 15. Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils) 16. Pseudoexfoliation 17. Keratoconus or irregular astigmatism 18. Inability to measure keratometry or biometry (including but not limited to cataract density, etc.) 19. Pathologic miosis 20. Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes 21. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial 22. Patients whose freedom is impaired by administrative or legal order 23. Concurrent participation in another clinical investigation in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm | 6 Months |
| Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m | 6 Months |
| Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus) | 6 Months |
| Mean monocular negative defocus range at the 0.20 logMAR compared to control | 6 Months |
| Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better | 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome (PRO) | 6 Months | Proportion of subjects who respond "I didn't wear glasses or contact lenses at all in the last 7 days" to question "How often did you wear glasses or contact lenses to see in the last 7 days?" from Patient Reported Outcome (PRO) survey |
Countries
Bulgaria, Czechia, Romania, Spain
Outcome results
None listed