EDoF IOLs vs Monofocal IOL

Carl Zeiss Meditec

Status: Completed

Conditions: Cataract

Treatments: Device: EDoF2; Device: Monofocal; Device: EDoF1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03172351

AT LARA 829MP BER-401-16

Details and patient eligibility

About

prospective, comparative (3 arms), randomized, multicentric clinical trial

Enrollment: 216 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;
• Patients of any gender, aged 50 to 80 years;
• Assured follow-up examinations;
• clinically significant bilateral cataract;

Exclusion criteria

• Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;
• Patients whose freedom is impaired by administrative or legal order;
• Current participation in another drug or device investigation;
• Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
• Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
• Pseudoexfoliations syndrome
• Pathologic miosis or Pharmacotherapy with miotic agent
• Keratoconus
• Chronic or recurrent uveitis
• Diabetic retinopathy
• Uncontrolled glaucoma and or IOP>24mmHg
• Choroidal hemorrhage,
• All kind of infections (acute ocular disease, external/internal infection, systemic infection)
• Traumatic cataract
• Aniridia
• Microphthalmia
• Amblyopia
• Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
• Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
• Previous intraocular and corneal surgery
• Expected postop. astigmatism greater than 1 D
• Any type of corneal disorder
• Systemic or ocular pharmacotherapy, which can impact the visual acuity,
• Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
• Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
• Dementia
• pregnancy or lactation period for female patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 3 patient groups

EDoF1

Experimental group

Treatment:

Device: EDoF2

Device: Monofocal

Monofocal

Active Comparator group

Treatment:

Device: EDoF1

Device: EDoF2

EDoF2

Active Comparator group

Treatment:

Device: EDoF1

Device: Monofocal