CataractNCT05750225
Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation
An observational study of Cataract and Pseudophakia, run by Medicontur Medical Engineering Ltd at 2 sites in Hungary.
Trial summary
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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, Intraocular Lens Complication
- What is being tested?
- Patient satisfaction questionnare
- How many people
- 52 participants
- Where
- 2 sitesHungary
- Study dates
- 2 Feb 2023to 7 Jun 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), who have undergone monocular or binocular 690AD or 690ADY IOL implantation.
Who may be able to join
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 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.
- Patients with the following condition(s) at the time of the baseline visit:
- Corneal astigmatism > 1.0 diopter
- 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
2 sites in 1 country.
Hungary2 sites
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
Nyíregyháza, 4400
Pécsi Tudományegyetem, Klinikai Központ Szemészeti Klinika
Pécs, 7632
About this study
Official title: Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 90 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
- Being tested
- Standard of care, Patient satisfaction questionnare
- 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 careOther
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 |
|---|---|---|
| 690AD IOL | 50 eyes /patients implanted with 690AD IOL Receives: Other: Standard of care; Other: Patient satisfaction questionnare | |
| 690ADY IOL | 50 eyes /patients implanted with 690ADY IOL Receives: Other: Standard of care; Other: Patient satisfaction questionnare |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDVA
Monocular corrected distance visual acuity (CDVA) To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.
Measured: 12 months postoperatively
Secondary outcomes (6)
UDVA
Monocular uncorrected distance visual acuity (UDVA) To compare monocular uncorrected distance visual acuity (UDVA) between groups implanted with 690AD and 690ADY monofocal IOLs 12 months postoperatively.
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 between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.
Measured: 12 months postoperatively
Spherical Equivalent
Spherical Equivalent shall be used to calculate manifest residual refraction. To compare sphere, cylinder and axis of the eye between groups implanted with 690AD and 690ADY monofocal IOLs 12 months after IOL implantation.
Measured: 12 months postoperatively
Patient satisfaction
Subjective perception of colour perception and scotopic vision shall be assessed by interviewing the patient using visual function questionnaire (VFQ-25 questionnaire) . To compare overall satisfaction, subjective perception of colour perception and scotopic vision between groups implanted with 690AD and 690ADY, postoperatively at 12 months.
Measured: 12 months postoperatively
Cylinder
Cylinder shall be used to calculate manifest residual refraction.
Measured: 12 months postoperatively
Axis of the eye
Axis of the eye shall be used to calculate manifest residual refraction.
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 posted1 Mar 2023
- Study start2 Feb 2023
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
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
- 52 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
- NCT05750225
- Sponsor's protocol ID
- M_690AD/690ADY_HU_2203
- Status last verified
- May 2023
- First submitted
- 9 Feb 2023
- Last updated
- 11 Jun 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Non-interventional, Comparative Clinical Investigation of the Safety and Performance of 690AD and 690ADY Monofocal Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT05750225
- Acronym / sponsor ID
- M_690AD/690ADY_HU_2203
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medicontur Medical Engineering LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 1 Mar 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.
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are 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 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022.
Data from five visits will be collected:
- Baseline preoperative (maximum 90 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 690AD IOL | – | Other: Standard of care, Other: Patient satisfaction questionnare50 eyes /patients implanted with 690AD IOL |
| 690ADY IOL | – | Other: Standard of care, Other: Patient satisfaction questionnare50 eyes /patients implanted with 690ADY IOL |
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), who have undergone monocular or binocular 690AD or 690ADY IOL implantation.
Key inclusion criteria (5 listed)
- Adult males or females above 18 years of age;
- Pseudophakic patients implanted with 690AD or 690ADY monofocal IOLs (implanted between September 2021 - March 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.
- 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. | Other | 690AD IOL, 690ADY IOL |
| Patient satisfaction questionnareVFQ- 25 (Visual Function Questionnare) to be completed during 12 month visit. | Other | 690AD IOL, 690ADY IOL |
Primary outcome
CDVA
Time frame: 12 months postoperatively
Monocular corrected distance visual acuity (CDVA) To compare monocular corrected distance visual acuity (CDVA) between groups implanted with 690AD and 690ADY monofocal IOLs at 12 months postoperatively.
6 secondary outcomes
UDVA
Time frame: 12 months postoperatively
UDVA and CDVA
Time frame: 12 months postoperatively
Spherical Equivalent
Time frame: 12 months postoperatively
Patient satisfaction
Time frame: 12 months postoperatively
Cylinder
Time frame: 12 months postoperatively
Axis of the eye
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 11 Jun 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.
2 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 Pseudophakia, run by Medicontur Medical Engineering Ltd at 2 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 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 11 Jun 2024.