Health TrialsbyHealthPanel

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

ConditionCataract Senile
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarl Zeiss Meditec AG

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDF

    Device

    Extended depth of focus

  • Monofocal IOL

    Device

    Monofocal

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Extended depth of focus (EDF)Experimental treatment 1 intervention
Group B: MonofocalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 Months
2

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

Time frame
6 Months
3

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

Time frame
6 Months
4

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

Time frame
6 Months

Secondary outcomes

1

Patient Reported Outcome (PRO)

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

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carl Zeiss Meditec AG

Lead sponsor

Source ClinicalTrials.gov
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