Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

NCT07092020 | Completed

• 1 other identifier: AT LARA 829MP BER-401-24
• Study Type: interventional
• Target: 220
• Locations: 4 countries
• Sites: 14

Brief Summary

Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)

Conditions

Cataract Senile

Keywords

IOL; Cataract

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Patient Reported Outcome (PRO)

  6 Months

Study Arms (2)

Extended depth of focus (EDF)

EXPERIMENTAL

Extended depth of focus

Device: EDF

Monofocal

ACTIVE COMPARATOR

Monofocal

Device: Monofocal IOL

Interventions

EDF DEVICE

Extended depth of focus

Extended depth of focus (EDF)

Monofocal IOL DEVICE

Monofocal

Monofocal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any gender, aged 18 years or older
• 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
• Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
• Calculated lens power within the available range
• Clear intraocular media other than cataract
• Patient is willing and capable of providing informed consent
• Patient is willing and capable of complying with visits and procedures as defined by this protocol

You may not qualify if:

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
• Endothelial cell count of less than 2000/mm2
• 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.
• 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
• 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
• 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.)
• Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• 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
• 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
• Clinically significant gonioscopic abnormalities
• Amblyopia, strabismus, single eye status
• Rubella, congenital, traumatic or complicated cataracts
• History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
• Microphthalmos or macrophthalmos
• Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (14)

Eye Hospital Zora

Sofia, Bulgaria

Location

Specialized Ophthalmological Hospital for Active Treatment

Sofia, Bulgaria

Location

Medical Center "Vereya"

Stara Zagora, Bulgaria

Location

Nemocnice Havlíčkův

Havlíčkův Brod, Czechia

Location

OFTEX ocni

Pardubice, Czechia

Location

Oční Centrum

Prague, Czechia

Location

Oculus Eye Clinic

Bucharest, Romania

Location

Ofta Total Clinic

Sibiu, Romania

Location

Medoptic Clinic

Suceava, Romania

Location

Oftalvist

Alicante, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

OMIQ Hospital Universitari

Sant Cugat del Vallès, Spain

Location

University Hopital Complex of Santiago de Compostela

Santiago de Compostela, Spain

Location

Oftalvist

Valencia, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 29, 2025
• Study Start: October 1, 2025
• Primary Completion: July 27, 2026
• Study Completion: July 27, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

BU (3); CZ (3); RO (3); ES (5)