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
1 other identifier
observational
64
1 country
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2020
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2024
CompletedFirst Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedOctober 15, 2024
October 1, 2024
3 years
October 10, 2024
October 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DCIVA
distance corrected intermediate visual acuity
measured at month 1, month 3, month 6 and month 12
Secondary Outcomes (5)
UDVA/CDVA
measured at month 1, month 3, month 6 and month 12
VADC
measured at month 3, month 6 and month 12
CSDC
measured at month 6 and month 12
Patient satisfaction
Evaluated at month 3 and month 12
CSV-1000
measured at month 3, month 6 and month 12
Other Outcomes (3)
Safety (intraoperative complications of cataract surgery)
Up to day 1 postoperatively
Safety (postoperative complications of cataract surgery)
Up to month 1 postoperatively
Safety (complications of IOL implantation)
Up to month 12 postoperatively
Study Arms (2)
877PAY (monofocal)
26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model
877PEY (extended depth of focus)
38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model
Interventions
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.
Eligibility Criteria
Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia), who hace signed the informed consent form and undergone binocular implantation with the investigational device (877PEY) or the comparator device (877PAY).
You may qualify if:
- cataractous patients who wish to be partly spectacle independent
- 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
You may not qualify if:
- corneal astigmatism \> 1.00 D
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, BAZ Vármegye, 3526, Hungary
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron Vármegye, 9024, Hungary
Retinaszerviz Kft.
Veszprém, Veszprém Vármegye, 8200, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
József F Győry, MD
Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 15, 2024
Study Start
December 2, 2020
Primary Completion
November 21, 2023
Study Completion
January 24, 2024
Last Updated
October 15, 2024
Record last verified: 2024-10