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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VFQ- 25 (Visual Function Questionnaire) | Behavioral | VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DCIVA | distance corrected intermediate visual acuity | measured at month 1, month 3, month 6 and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| UDVA/CDVA | uncorrected and corrected distance visual acuity | measured at month 1, month 3, month 6 and month 12 |
| VADC | visual acuity defocus curves |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (intraoperative complications of cataract surgery) |
| Up to day 1 postoperatively |
| Safety (postoperative complications of cataract surgery) |
Inclusion Criteria:
Exclusion Criteria:
Intraoperative exclusion criteria:
tear in capsulorhexis*
zonular dehiscence*
posterior capsular rupture vitreous loss and other unexpected surgical complication*
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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).
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| Name | Affiliation | Role |
|---|---|---|
| József F Győry, MD | Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház | Miskolc | BAZ Vármegye | 3526 | Hungary | ||
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| Optical Biometry | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer. |
|
| VADC | Diagnostic Test | 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 | Diagnostic Test | Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application |
|
| CSV-1000 | Diagnostic Test | 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:
|
|
| Tear film stability | Diagnostic Test | 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 | Device | The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery. |
|
| measured at month 3, month 6 and month 12 |
| CSDC | contrast sensitivity defocus curves | measured at month 6 and month 12 |
| Patient satisfaction | presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire. | Evaluated at month 3 and month 12 |
| CSV-1000 | Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument | measured at month 3, month 6 and month 12 |
|
| Up to month 1 postoperatively |
| Safety (complications of IOL implantation) |
| Up to month 12 postoperatively |
| Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház |
| Győr |
| Győr-Moson-Sopron Vármegye |
| 9024 |
| Hungary |
| Retinaszerviz Kft. | Veszprém | Veszprém Vármegye | 8200 | Hungary |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000072776 | Slit Lamp Microscopy |
| D009887 | Ophthalmoscopy |
| ID | Term |
|---|---|
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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