The purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a Medicontur monofocal (877PAY) or a Medicontur extended depth of focus (877PEY) IOL models. The visit schedule included a total of 6 visits, in addition to the IOL implantation surgery, with the listed follow-up timeline: * screening and baseline assessments * day 0 (IOL implantation surgery) * day 1 * month 1 * month 3 * month 6 * month 12
Study Type
OBSERVATIONAL
Enrollment
64
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
Axial length, anterior chamber depth and corneal keratometric values K1-K2. All these parameters were measured at the screening visit and at the month 3 follow-up visit, using the ARGOS® Biometer or the ANTERION® Cataract App
The fundus and other ocular structures, such as the cornea, anterior chamber, iris, pupil, crystalline lens / IOL alignment, corpus ciliare and choroid were examined at screening visit, on the day of the surgery, and at the follow up visits D1, M1, M3, M6, and M12, using the slit lamp binocular indirect ophthalmoscopy.
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
Uncorrected and Distance Corrected Intermediate Visual acuity (UIVA / DCIVA) was evaluated postoperatively at M1, M3, M6 and M12, using an intermediate chart from 67 cm.
Uncorrected and Distance Corrected Near Visual acuity (UNVA / DCNVA) was evaluated postoperatively at M1, M3, M6 and M12, using a near chart from 40 cm.
Manifest refraction was the monocular subjective refraction (Sph, Cyl, Axis) giving the best distance corrected visual acuity. It was measured at the screening visit and the follow-up visits Day 1, Month 1, Month 3, Month 6 and Month 12.
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
Visual Acuity Defocus Curve (VADC) was taken monocularly at M3, monocularly and binocularly at M6 and binocularly at M12, using the Multifocal Lens analyzer - MLA application.
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
Contrast Sensitivity was measured using the CSV-1000 with distance correction in place at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd). Measurements were taken under four different light conditions: * Photopic (M3 monocular and binocular, M6 binocular and M12 monocular) * Mesopic (M6 binocular) * Photopic with backlight (M6 binocular) * Mesopic with backlight (M6 binocular)
Tear film stability was assessed at screening visit and at follow-up visits M1, M3, M6, and M12 using the non-invasive Tear break Up Time (TBUT) with fluorescein dye.
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, BAZ Vármegye, Hungary
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron Vármegye, Hungary
Retinaszerviz Kft.
Veszprém, Veszprém Vármegye, Hungary
DCIVA
distance corrected intermediate visual acuity
Time frame: measured at month 1, month 3, month 6 and month 12
UDVA/CDVA
uncorrected and corrected distance visual acuity
Time frame: measured at month 1, month 3, month 6 and month 12
VADC
visual acuity defocus curves
Time frame: measured at month 3, month 6 and month 12
CSDC
contrast sensitivity defocus curves
Time frame: measured at month 6 and month 12
Patient satisfaction
presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire.
Time frame: Evaluated at month 3 and month 12
CSV-1000
Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument
Time frame: measured at month 3, month 6 and month 12
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