Cataract, Presbyopia, Ametropia
Conditions
Keywords
Intraocular lens, monofocal IOL, EDOF
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
Interventions
DIAGNOSTIC_TESTOptical 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
BEHAVIORALVFQ- 25 (Visual Function Questionnaire)
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
DIAGNOSTIC_TESTSlit 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.
DIAGNOSTIC_TESTUDVA
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
DIAGNOSTIC_TESTCDVA
Monocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart.
DIAGNOSTIC_TESTUIVA / 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.
DIAGNOSTIC_TESTUNVA / 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.
DIAGNOSTIC_TESTManifest 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.
DIAGNOSTIC_TESTIOP
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
DIAGNOSTIC_TESTVADC
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.
DIAGNOSTIC_TESTCSDC
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
DIAGNOSTIC_TESTCSV-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)
DIAGNOSTIC_TESTTear 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.
DEVICEIOL implantation
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
Sponsors
Medicontur Medical Engineering Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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 Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DCIVA | measured at month 1, month 3, month 6 and month 12 | distance corrected intermediate visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VADC | measured at month 3, month 6 and month 12 | visual acuity defocus curves |
| CSDC | measured at month 6 and month 12 | contrast sensitivity defocus curves |
| Patient satisfaction | Evaluated at month 3 and month 12 | presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire. |
| CSV-1000 | measured at month 3, month 6 and month 12 | Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument |
| UDVA/CDVA | measured at month 1, month 3, month 6 and month 12 | uncorrected and corrected distance visual acuity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety (complications of IOL implantation) | Up to month 12 postoperatively | * Posterior capsular opacification (PCO) * Opacification, IOL discoloration |
| Safety (postoperative complications of cataract surgery) | Up to month 1 postoperatively | * 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 |
| Safety (intraoperative complications of cataract surgery) | Up to day 1 postoperatively | * 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 |
Countries
Hungary
Outcome results
None listed