EDF IOL Versus Monofocal IOL

NCT ID: NCT07092020

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-10-31

Brief Summary

EDF intraocular lens versus Monofocal intraocular lens

Detailed Description

Extended depth of Focus intraocular lens versus a monofocal intraocular lens

Conditions

Cataract Senile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EDF

Extended depth of focus

Group Type: EXPERIMENTAL

EDF

Intervention Type: DEVICE

Extended depth of focus

Monofocal

Monofocal

Group Type: ACTIVE_COMPARATOR

Monofocal IOL

Intervention Type: DEVICE

Monofocal

Interventions

EDF

Extended depth of focus

Intervention Type: DEVICE

Monofocal IOL

Monofocal

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Hospital Zora

Sofia, , Bulgaria

Specialized Ophthalmological Hospital for Active Treatment

Sofia, , Bulgaria

Medical Center "Vereya"

Stara Zagora, , Bulgaria

Nemocnice Havlíčkův

Havlíčkův Brod, , Czechia

OFTEX ocni

Pardubice, , Czechia

Oční Centrum

Prague, , Czechia

Oculus Eye Clinic

Bucharest, , Romania

Ofta Total Clinic

Sibiu, , Romania

Medoptic Clinic

Suceava, , Romania

Oftalvist

Alicante, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

OMIQ Hospital Universitari

Sant Cugat del Vallès, , Spain

University Hopital Complex of Santiago de Compostela

Santiago de Compostela, , Spain

Oftalvist

Valencia, , Spain

Countries

Bulgaria; Czechia; Romania; Spain

Central Contacts

Carl Zeiss Meditec AG

Role: CONTACT

info@zeiss.com

+49308540010

Facility Contacts

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Other Identifiers

AT LARA 829MP BER-401-24

Identifier Type: -

Identifier Source: org_study_id