RecruitingNot Applicable

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

Bulgaria, Czechia220 participantsStarted 2025-10-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm

Timeframe: 6 Months

Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m

Timeframe: 6 Months

Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus)

Timeframe: 6 Months

Mean monocular negative defocus range at the 0.20 logMAR compared to control

Timeframe: 6 Months

Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better

Timeframe: 6 Months

Trial details

NCT IDNCT07092020

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Carl Zeiss Meditec AG

+49308540010 info@zeiss.com

View on ClinicalTrials.gov More Cataract Senile trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm

Timeframe: 6 Months

Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m

Timeframe: 6 Months

Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus)

Timeframe: 6 Months

Mean monocular negative defocus range at the 0.20 logMAR compared to control

Timeframe: 6 Months

Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better

Timeframe: 6 Months