Health TrialsbyHealthPanel

Vivinex Impress XY1-EM vs RayOne EMV

ConditionCataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorMedical University of Bialystok

About this trial

Comparison of the outcomes of bilateral implantation of extended depth of vision (EDOF) intraocular lenses (IOLs): the Rayone EMV and the Vivinex Impress XY1-EM in patients with cataract

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age-related bilateral cataract

age 21 or older

visual acuity > 0.05

axial length: 22.0 - 26.0 mm

Disqualifiers

active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)

relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)

corneal decompensation or corneal endothelial cell insufficiency

previous ocular surgery or trauma

Trial design

Design model

Parallel

Treatments tested in this trial

  • RayOne EMV

    Device

    non-diffractive monofocal IOL

  • Vivinex Impress

    Device

    non-diffractive monofocal IOL

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Rayone EMVExperimental treatment 1 intervention
Group B: Vivinex Impress XY1-EMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual acuity at intermediate distance

The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs. The higer the number the better outcome.

Time frame
3 months

Secondary outcomes

1

Visual acuity at far distance

The visual acuity at the far distance will be measured using ETDRS charts at a distance of 4 metres and compared between the two different IOLs. The higer the number the better outcome.

Time frame
3 months
2

Visual acuity at near distance

The visual acuity at the near distance will be measured using ETDRS charts at a distance of 40 centimetres and compared between the two different IOLs. The higer the number the better outcome.

Time frame
3 months
3

Change from baseline in the quality of life

Patients' quality of vision will be measured with the Visual Function Index Questionnaire and compared to outcome prior surgery

Time frame
3 months

Other outcomes

Sponsors and contacts

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

Medical University of Bialystok

Lead sponsor

Source ClinicalTrials.gov
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