CataractNCT06578910
Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
An observational study of Cataract and Pseudophakia, run by Medicontur Medical Engineering Ltd at 1 site in Hungary.
Trial summary
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Pseudophakia
- What is being tested?
- Patient satisfaction questionnare
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 23 May 2023to 25 Apr 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 have undergone monocular or binocular implantation with the 640AD IOL model.
Who may be able to join
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
- Diagnosis of cataract and/or ametropia (hyperopia, myopia);
- Subject who has signed an informed consent form.
- Patients who have participated in all visits that are subject to retrospective data collection.
Who cannot join
- Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
- Patients with the following condition(s) at the time of the baseline visit:
- Corneal astigmatism > 1.5 D
- Uncontrolled diabetic retinopathy
- Iris neovascularization
- Congenital eye abnormality
Show all 23Show fewer
- Uncontrolled glaucoma
- Pseudoexfoliation syndrome
- Amblyopia
- Uveitis
- AMD (advanced AMD)
- Retinal detachment
- Prior ocular surgery in personal medical history
- Previous laser treatment
- Corneal diseases
- Severe retinal diseases (dystrophy, degeneration)
- High myopia
- Inadequate visualization of the fundus on preoperative examination
- Patients deemed by the clinical investigator because of any systemic disease
- Pregnancy
- Eye trauma in medical history
- Current use of systemic steroids or topical ocular medication
- Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
SZTE ÁOK Szent-Györgyi Albert Klinikai Központ Szemészeti Klinika
Szeged, 6720
About this study
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
Read more
The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 30 days prior to surgery)- retrospective
- IOL implantation Day 0 - retrospective
- Postoperative visit at Day 1 (+/- 0 days) - retrospective
- Postoperative visit at 1 month (+/- 2 weeks) - retrospective
- Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit
- Conditions
- Cataract, Pseudophakia
- Being tested
- Standard of care, Patient satisfaction questionnare
- Keywords
- Intraocular lens, Ametropia - correction, Presbyopia- correction
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDiagnostic test
12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction.
Patient satisfaction questionnareOther
VFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit.
| Study group | Role | What they receive |
|---|---|---|
| 640AD | 80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly Receives: Diagnostic Test: Standard of care; Other: Patient satisfaction questionnare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular corrected distance visual acuity (CDVA)
To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.
Measured: 12 months postoperatively
Secondary outcomes (4)
Monocular uncorrected distance visual acuity (UDVA)
To compare monocular uncorrected distance visual acuity (UDVA) at 12 months postoperative and preoperative status.
Measured: 12 months postoperatively
UDVA and CDVA
To compare percentage of eyes that achieve monocular UDVA and monocular CDVA within logMAR 0.0 or 0.3 at 12 months postoperative and preoperative status.
Measured: 12 months postoperatively
Manifest residual refraction
To compare residual SPH at 12 months postoperative and preoperative status. (Residual CYL and axis are not applicable, as it is a monofocal IOL, that does not correct astigmatism)
Measured: 12 months postoperatively
Patient satisfaction
Visual Function Questionnaire 25 (National Eye Institute) is used to evaluate overall satisfaction, subjective perception of colour perception and scotopic vision at 12 months postoperatively. The results are evaluated according to the official evaluation guide.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start23 May 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 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
- Other
- Enrolment
- 80 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
- NCT06578910
- Sponsor's protocol ID
- M_640AD_HU_2204
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT06578910
- Acronym / sponsor ID
- M_640AD_HU_2204
- Conditions
- Cataract, Pseudophakia
- Keywords
- Intraocular lens, Ametropia - correction, Presbyopia- correction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 30 Aug 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.
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens.
The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.
The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 640AD IOLs mono- or binocularly between December 2021 - December 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 30 days prior to surgery)- retrospective
- IOL implantation Day 0 - retrospective
- Postoperative visit at Day 1 (+/- 0 days) - retrospective
- Postoperative visit at 1 month (+/- 2 weeks) - retrospective
- Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 640AD | – | Diagnostic Test: Standard of care, Other: Patient satisfaction questionnare80 patients (105 eyes) implanted with 640AD IOL monocularly or binocularly |
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 have undergone monocular or binocular implantation with the 640AD IOL model.
Key inclusion criteria (5 listed)
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 640AD monofocal IOLs (implanted between December 2021 - December 2022);
- Diagnosis of cataract and/or ametropia (hyperopia, myopia);
- Subject who has signed an informed consent form.
- Patients who have participated in all visits that are subject to retrospective data collection.
Key exclusion criteria (23 listed)
- Patients who are not targeted to emmetropia ( outside -0,5 and 0,5 D)
- Patients with the following condition(s) at the time of the baseline visit:
- Patients with any eye condition that could affect vision in the opinion of the investigator at the time of the 12-month follow-up: (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.)
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 |
|---|---|---|
| Standard of care12 months after the IOL implantation: measurement of intraocular pressure, slitlamp and fundus examination, visual acuity, manifest refraction. | Diagnostic test | 640AD |
| Patient satisfaction questionnareVFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit. | Other | 640AD |
Primary outcome
Monocular corrected distance visual acuity (CDVA)
Time frame: 12 months postoperatively
To compare monocular corrected distance visual acuity (CDVA) between 12 months postoperative and preoperative results.
4 secondary outcomes
Monocular uncorrected distance visual acuity (UDVA)
Time frame: 12 months postoperatively
UDVA and CDVA
Time frame: 12 months postoperatively
Manifest residual refraction
Time frame: 12 months postoperatively
Patient satisfaction
Time frame: 12 months postoperatively
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 30 Aug 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.
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 Pseudophakia, run by Medicontur Medical Engineering Ltd at 1 site 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 5 inclusion and 23 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 30 Aug 2024. 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 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?
Monocular corrected distance visual acuity (CDVA) (time frame: 12 months postoperatively). 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 30 Aug 2024.