CataractNCT06642779
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
An observational study of Cataract and Presbyopia, run by Medicontur Medical Engineering Ltd at 3 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia, Ametropia
- What is being tested?
- VFQ- 25 (Visual Function Questionnaire), Optical Biometry and Slit lamps / Fundoscopy / Biomicroscopy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 3 sitesHungary
- Study dates
- 2 Dec 2020to 24 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- corneal astigmatism > 1.00 D
- irregular astigmatism
- diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
- congenital eye abnormality
Show all 25Show fewer
- 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 exclusion criteria:
- tear in capsulorhexis*
- zonular dehiscence*
- posterior capsular rupture vitreous loss and other unexpected surgical complication*
- According to coordinator investigator's decision, the marked inclusion and exclusion criteria were not applied.
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház
Győr, Győr-Moson-Sopron Vármegye, 9024
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, BAZ Vármegye, 3526
Retinaszerviz Kft.
Veszprém, Veszprém Vármegye, 8200
About this study
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
- Conditions
- Cataract, Presbyopia, Ametropia
- Being tested
- VFQ- 25 (Visual Function Questionnaire), Optical Biometry, Slit lamps / Fundoscopy / Biomicroscopy, UDVA, CDVA
- Keywords
- Intraocular lens, monofocal IOL, EDOF
- Medical subject headings
- Cataract, Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VFQ- 25 (Visual Function Questionnaire)Behavioural
VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits.
Optical BiometryDiagnostic 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 / BiomicroscopyDiagnostic 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.
UDVADiagnostic 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.
CDVADiagnostic 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 / DCIVADiagnostic 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 / DCNVADiagnostic 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 RefractionDiagnostic 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.
IOPDiagnostic test
Intraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer.
VADCDiagnostic 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.
CSDCDiagnostic test
Contrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application
CSV-1000Diagnostic 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:
- 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 stabilityDiagnostic 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 implantationDevice
The investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery.
| Study group | Role | What they receive |
|---|---|---|
| 877PAY (monofocal) | 26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model Receives: 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 | |
| 877PEY (extended depth of focus) | 38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCIVA
distance corrected intermediate visual acuity
Measured: measured at month 1, month 3, month 6 and month 12
Secondary outcomes (5)
UDVA/CDVA
uncorrected and corrected distance visual acuity
Measured: measured at month 1, month 3, month 6 and month 12
VADC
visual acuity defocus curves
Measured: measured at month 3, month 6 and month 12
CSDC
contrast sensitivity defocus curves
Measured: measured at month 6 and month 12
Patient satisfaction
presence of visual disturbances (glares, halos), evaluated with the VFQ-25 questionnaire.
Measured: Evaluated at month 3 and month 12
CSV-1000
Contrast sensitivity measured with the CSV-1000 standardized auto-calibrating vision testing instrument
Measured: measured at month 3, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start2 Dec 2020
- Primary completion21 Nov 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicontur Medical Engineering Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- József F Győry, MD, Principal investigator, Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642779
- Sponsor's protocol ID
- M_877PAY_877PEY_HU_2020
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06642779
- Acronym / sponsor ID
- M_877PAY_877PEY_HU_2020
- Conditions
- Cataract, Presbyopia, Ametropia
- Keywords
- Intraocular lens, monofocal IOL, EDOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 877PAY (monofocal) | – | 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 implantation26 patients (52 eyes) binocularly implanted with the 877PAY monofocal IOL model |
| 877PEY (extended depth of focus) | – | 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 implantation38 patients (76 eyes) binocularly implanted with the 877PEY extended depth of focus IOL model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (25 listed)
- corneal astigmatism > 1.00 D
- irregular astigmatism
- diabetic retinopathy
- iris neovascularisation
- serious intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VFQ- 25 (Visual Function Questionnaire)VFQ-25 questionnaire was used to evaluate patient satisfaction at the M3 and M12 visits. | Behavioural | 877PAY (monofocal), 877PEY (extended depth of focus) |
| Optical BiometryAxial 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 | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| Slit lamps / Fundoscopy / BiomicroscopyThe 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| UDVAMonocular and binocular Uncorrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart. | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| CDVAMonocular and binocular Corrected Distance Visual Acuity (UDVA) was evaluated at all visits (preoperative, D1, M1, M3, M6 and M12), using the ETDRS chart. | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| UIVA / DCIVAUncorrected 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| UNVA / DCNVAUncorrected 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| Manifest RefractionManifest 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| IOPIntraocular pressure (IOP) was measured at all visits (preoperative, D1, M1, M3, M6 and M12), using a non-contact tonometer. | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| VADCVisual 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| CSDCContrast Sinsitivity Defocus Curve (CSDC) was taken under photopic conditions at M6 and M12, using the Multifocal Lens Analyzer - MLA application | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| CSV-1000Contrast 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 test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| Tear film stabilityTear 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. | Diagnostic test | 877PAY (monofocal), 877PEY (extended depth of focus) |
| IOL implantationThe investigational device (877PEY) and the comparator (877PAY) intraocular lens models were implanted, using sutureless, small-incision phacoemulsification surgery. | Device | 877PAY (monofocal), 877PEY (extended depth of focus) |
Primary outcome
DCIVA
Time frame: measured at month 1, month 3, month 6 and month 12
distance corrected intermediate visual acuity
5 secondary outcomes
UDVA/CDVA
Time frame: measured at month 1, month 3, month 6 and month 12
VADC
Time frame: measured at month 3, month 6 and month 12
CSDC
Time frame: measured at month 6 and month 12
Patient satisfaction
Time frame: Evaluated at month 3 and month 12
CSV-1000
Time frame: measured at month 3, month 6 and month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
József F Győry, MD principal investigator
Retinaszerviz Kft. (8200 Veszprém, Vörösmarty tér 6, Hungary)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Presbyopia, run by Medicontur Medical Engineering Ltd at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCIVA (time frame: measured at month 1, month 3, month 6 and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.