About this trial
Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age-related bilateral cataract
Age 21 or older
Visual acuity > 0.05
For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
Disqualifiers
Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
Corneal decompensation or corneal endothelial cell insufficiency
Irregular astigmatism on corneal tomography
Trial design
Parallel
Treatments tested in this trial
Low-Add EDOF IOL
DeviceAcunex Vario AN6V
EDOF IOL
DevicePureSee EDOF IOL
Treatment groups
Trial outcomes
Primary outcomes
Distance corrected visual acuity for intermediate distance
Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Secondary outcomes
Uncorrected visual acuity for intermediate distance
Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts
Uncorrected and distance corrected visual acuity for far distance
Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts
Uncorrected and distance corrected visual acuity for near distance
Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts
Defocus curve assessment
Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart
Sponsors and contacts
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