Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL
NCT ID: NCT06642779
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
64 participants
OBSERVATIONAL
2020-12-02
2024-01-24
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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877PAY (monofocal)
26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model
VFQ- 25 (Visual Function Questionnaire)
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
Optical Biometry
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
Slit lamps / Fundoscopy / Biomicroscopy
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.
UDVA
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
CDVA
Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
UIVA / DCIVA
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.
UNVA / DCNVA
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
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.
IOP
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
VADC
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.
CSDC
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
CSV-1000
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
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.
IOL implantation
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
877PEY (extended depth of focus)
38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model
VFQ- 25 (Visual Function Questionnaire)
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
Optical Biometry
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
Slit lamps / Fundoscopy / Biomicroscopy
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.
UDVA
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
CDVA
Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
UIVA / DCIVA
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.
UNVA / DCNVA
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
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.
IOP
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
VADC
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.
CSDC
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
CSV-1000
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
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.
IOL implantation
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
Interventions
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VFQ- 25 (Visual Function Questionnaire)
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
Optical Biometry
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
Slit lamps / Fundoscopy / Biomicroscopy
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.
UDVA
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
CDVA
Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
UIVA / DCIVA
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.
UNVA / DCNVA
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
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.
IOP
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
VADC
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.
CSDC
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
CSV-1000
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
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.
IOL implantation
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
Eligibility Criteria
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Inclusion Criteria
* cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms\*
* best corrected visual acuity to be better than 20/25 (0.1 logMAR) after cataract removal and IOL implantation\*
* ≤ 1.0 D of preoperative keratometric astigmatism;
* clear intraocular media other than cataract;
* given written informed consent by subject;
* subjects are willing and able to comply with schedule for follow-up visits;
* adult patient
Exclusion Criteria
* irregular astigmatism
* diabetic retinopathy
* iris neovascularisation
* serious intraoperative complications
* congenital eye abnormality
* uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field
* pseudoexfoliation syndrome
* amblyopia
* uveitis
* long-term anti-inflammatory treatment
* AMD
* retinal detachment
* prior ocular surgery in personal medical history
* corneal diseases
* severe retinal diseases (dystrophy, degeneration)
* severe myopia (if required IOL power is lower than 10 D)
* inadequate visualization of the fundus on preoperative examination
* patients deemed by the clinical investigator because of any systemic disease.
* eye trauma in medical history
* tear in capsulorhexis\*
* zonular dehiscence\*
* posterior capsular rupture vitreous loss and other unexpected surgical complication\*
18 Years
ALL
No
Sponsors
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Medicontur Medical Engineering Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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József F Győry, MD
Role: PRINCIPAL_INVESTIGATOR
Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
Locations
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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
Countries
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Other Identifiers
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M_877PAY_877PEY_HU_2020
Identifier Type: -
Identifier Source: org_study_id
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