An observational study in Cataract, Presbyopia and Ametropia, sponsored by Medicontur Medical Engineering Ltd. Completed at 3 sites in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Medicontur Medical Engineering Ltd · Observational
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:
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 64 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Medicontur Medical Engineering Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intraoperative exclusion criteria:
posterior capsular rupture vitreous loss and other unexpected surgical complication*
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model
Behavioral: VFQ- 25 (Visual Function Questionnaire) · Diagnostic Test: Optical Biometry · Diagnostic Test: Slit lamps / Fundoscopy / Biomicroscopy · Diagnostic Test: UDVA · Diagnostic Test: CDVA · Diagnostic Test: UIVA / DCIVA · Diagnostic Test: UNVA / DCNVA · Diagnostic Test: Manifest Refraction · Diagnostic Test: IOP · Diagnostic Test: VADC · Diagnostic Test: CSDC · Diagnostic Test: CSV-1000 · Diagnostic Test: Tear film stability · Device: IOL implantation
38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model
Behavioral: VFQ- 25 (Visual Function Questionnaire) · Diagnostic Test: Optical Biometry · Diagnostic Test: Slit lamps / Fundoscopy / Biomicroscopy · Diagnostic Test: UDVA · Diagnostic Test: CDVA · Diagnostic Test: UIVA / DCIVA · Diagnostic Test: UNVA / DCNVA · Diagnostic Test: Manifest Refraction · Diagnostic Test: IOP · Diagnostic Test: VADC · Diagnostic Test: CSDC · Diagnostic Test: CSV-1000 · Diagnostic Test: Tear film stability · Device: IOL implantation
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.
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
Safety (intraoperative complications of cataract surgery)
* Posterior capsular or zonular rupture * Vitreous loss/anterior vitrectomy or aspiration * Iris/ciliary body injury * Loss of nuclear material into vitreous * Suprachoroidal haemorrhage * Retrobulbar hemorrhage
Time frame: Up to day 1 postoperatively
Safety (postoperative complications of cataract surgery)
* Cystoid macular edema * Iris abnormalities * Corneal edema * Wound leak or rupture * IOL dislocation, removal, or exchange * Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon) * Retinal tear, break, or detachment * Persistent iritis * Elevated intraocular pressure * Pupillary block * Cornea status
Time frame: Up to month 1 postoperatively
Safety (complications of IOL implantation)
* Posterior capsular opacification (PCO) * Opacification, IOL discoloration
Time frame: Up to month 12 postoperatively
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Medicontur Medical Engineering Ltd