Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-105
SponsorVienna Institute for Research in Ocular Surgery

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Low-Add EDOF IOL

    Device

    Acunex Vario AN6V

  • EDOF IOL

    Device

    PureSee EDOF IOL

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Acunex Vario AN6VExperimental treatment 1 intervention
Group B: PureSeeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

Uncorrected visual acuity for intermediate distance

Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts

Time frame
6 months
2

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

Time frame
6 months
3

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

Time frame
6 months
4

Defocus curve assessment

Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart

Time frame
6 months

Other outcomes

Sponsors and contacts

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