CataractNCT05735990
Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
An observational study of Cataract and Presbyopia, run by Medicontur Medical Engineering Ltd at 1 site in Spain.
Trial summary
The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia, Hyperopia
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2022to 31 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia, who has binocular 640PM IOL implantation.
Who may be able to join
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);
- Diagnosis of cataract and/or ametropia and/or presbyopia;
- Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation
- Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.
Who cannot join
- Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
- regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.
Trial locations and contacts
1 site in 1 country.
About this study
The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:
- Preoperative status: Preoperative Screening and Baseline
- Surgery: IOL implantation
- M1: 1 month +/- 2 weeks postoperative follow-up
- M3: 3 months +/- 1 month postoperative follow-up
- M12: 12 months +/- 3 months postoperative follow-up
- Conditions
- Cataract, Presbyopia, Hyperopia, Myopia, Pseudophakia
- Being tested
- Intraocular lens
- Medical subject headings
- Cataract, Presbyopia, Hyperopia, Myopia, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Aspheric hydrophilic acrylic IOL for implantation into the capsular bag
| Study group | Role | What they receive |
|---|---|---|
| 640PM implanted | Patients implanted binocularly with Medicontur's intraocular lens model 640PM. Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity (CDVA);
Measured: 12 months after IOL implantation
Secondary outcomes (9)
visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)
Measured: 1 and 12 months after IOL implantation;
Manifest spherical equivalent refraction (SEQ)
Measured: 3 and 12 months after IOL implantation
VADC (monocular with best distance correction) under photopic conditions
Measured: 3 months after IOL implantation
CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions
Measured: 3 months after IOL implantation;
CSDC (binocular without best distance correction) under photopic and mesopic conditions
Measured: 12 months after IOL implantation;
Visual Function by VF-14
Measured: 12 months after IOL implantation;
Patient satisfaction self-reported by the participant
Measured: 12 months after IOL implantation
Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant
Measured: 12 months after IOL implantation
spectacle independence self-reported by the participant
Measured: 12 months after IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Oct 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicontur Medical Engineering Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735990
- Sponsor's protocol ID
- M_640PM_ES_2202
- Status last verified
- Feb 2023
- First submitted
- 28 Oct 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez J, Srinivasan S, Burguera N, Martinez J, Rodriguez-Vallejo M. One-year follow-up of a multifocal intraocular lens with optimized elevated phase shift. J Cataract Refract Surg. 2023 Oct 1;49(10):1018-1024. doi: 10.1097/j.jcrs.0000000000001266.
PubMed 37464551
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
- ClinicalTrials.gov ID
- NCT05735990
- Acronym / sponsor ID
- M_640PM_ES_2202
- Conditions
- Cataract, Presbyopia, Hyperopia, Myopia, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 21 Feb 2023 (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 clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:
- Preoperative status: Preoperative Screening and Baseline
- Surgery: IOL implantation
- M1: 1 month +/- 2 weeks postoperative follow-up
- M3: 3 months +/- 1 month postoperative follow-up
- M12: 12 months +/- 3 months postoperative follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 640PM implanted | – | Device: Intraocular lensPatients implanted binocularly with Medicontur's intraocular lens model 640PM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia, who has binocular 640PM IOL implantation.
Key inclusion criteria (5 listed)
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);
- Diagnosis of cataract and/or ametropia and/or presbyopia;
- Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation
- Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.
Key exclusion criteria (2 listed)
- Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);
- regular anterior corneal astigmatism ≥ 1.20 D or irregular astigmatism ≥ 0.5 μm measured with Pentacam at 4 mm.
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 |
|---|---|---|
| Intraocular lensAspheric hydrophilic acrylic IOL for implantation into the capsular bag | Device | 640PM implanted |
Primary outcome
Corrected distance visual acuity (CDVA);
Time frame: 12 months after IOL implantation
9 secondary outcomes
visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)
Time frame: 1 and 12 months after IOL implantation;
Manifest spherical equivalent refraction (SEQ)
Time frame: 3 and 12 months after IOL implantation
VADC (monocular with best distance correction) under photopic conditions
Time frame: 3 months after IOL implantation
CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions
Time frame: 3 months after IOL implantation;
CSDC (binocular without best distance correction) under photopic and mesopic conditions
Time frame: 12 months after IOL implantation;
Visual Function by VF-14
Time frame: 12 months after IOL implantation;
Patient satisfaction self-reported by the participant
Time frame: 12 months after IOL implantation
Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant
Time frame: 12 months after IOL implantation
spectacle independence self-reported by the participant
Time frame: 12 months after IOL implantation
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 21 Feb 2023.
- Derived from this study: PubMed 37464551Fernandez J, Srinivasan S, Burguera N, Martinez J, Rodriguez-Vallejo M. One-year follow-up of a multifocal intraocular lens with optimized elevated phase shift. J Cataract Refract Surg. 2023 Oct 1;49(10):1018-1024. doi: 10.1097/j.jcrs.0000000000001266.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 1 site in Spain.
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 5 inclusion and 2 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Corrected distance visual acuity (CDVA); (time frame: 12 months after IOL implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735990, which also lists 1 linked publication.
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 21 Feb 2023.