EDF IOL Versus Monofocal IOL

Carl Zeiss Meditec

Status: Not yet enrolling

Conditions: Cataract Senile

Treatments: Device: EDF; Device: Monofocal IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT07092020

AT LARA 829MP BER-401-24

Details and patient eligibility

About

EDF intraocular lens versus Monofocal intraocular lens

Full description

Extended depth of Focus intraocular lens versus a monofocal intraocular lens

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

EDF

Experimental group

Description:

Extended depth of focus

Treatment:

Device: EDF

Monofocal

Active Comparator group

Description:

Monofocal

Treatment:

Device: Monofocal IOL