EDF IOL Versus Monofocal IOL

Not Applicable

Not yet recruiting

• Conditions: Cataract Senile

• Registration Number: NCT07092020
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

EDF intraocular lens versus Monofocal intraocular lens

Detailed Description

Extended depth of Focus intraocular lens versus a monofocal intraocular lens

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-12-01
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean monocular DCIVA at 66 cm	6 Months
Mean monocular CDVA at 4 m	6 Months
Mean monocular 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 CDVA 0.30 logMAR or better	6 Months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

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; 🇷🇴 Bucuresti, Romania

Ofta Total Clinic; 🇷🇴 Sibiu, Romania

Medoptic Clinic; 🇷🇴 Suceava, Romania

Oftalvist; 🇪🇸 Valencia, Spain

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