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PresbyopiaNCT05596682

Prospective Multicenter Clinical Study on the Visual and Refractive Outcomes and Safety Outcomes Following Implantation of an AddOn Intraocular Lens in Previously Pseudophakic Eyes

An observational study of Presbyopia and Refractive Errors, run by Medicontur Medical Engineering Ltd at 4 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this prospective multicenter clinical study is to evaluate the visual and refractive outcomes and safety outcomes following bilateral implantation of trifocal and/or trifocal toric 1stQ AddOn (Medicontur) intraocular lenses (IOLs) to correct residual refractive errors, astigmatism, and presbyopia in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
supplementary intraocular lenses
Type of treatment
Medical device
How many people
75 participants
Where
4 sitesin 4 countries
Study dates
17 Oct 2022to 31 Aug 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Pseudophakic subjects after uncomplicated implantation of a monofocal intraocular lens (IOL) in the capsular bag who have elected to undergo a secondary add-on IOL procedure to correct presbyopia and/or the residual refractive and/or cylindric error after primary lens implantation

Who may be able to join

  • The subject must read and sign the Informed Consent form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Adult males or females above 18 years of age.
  • No other ocular co -morbidity (i.e. no history of ocular surface disease, severe dry eye, glaucoma, retinal or macular pathology)
  • Pseudophakia.
  • Uncomplicated cataract surgery or clear lens extraction followed by an uneventful recovery period of at least 3-months.
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  • Stable primary IOL located in the capsular bag.
  • Anterior chamber depth (ACD) of at least 2.8 mm (measured from corneal endothelium to the anterior surface of the primary IOL in the capsular bag with an optical biometer [Lenstar, IOL Master]).
  • Subjects with residual refractive error that is suitable for correction with a secondary add-on IOL.
  • Subjects, who have stable post-operative refraction at month two following uncomplicated primary lens surgery.
  • Subjects with myopia of not more than 6.0 diopters.
  • Subjects with monocular corrected distance visual acuity (CDVA) of Snellen 6/7.5 (20/25; LogMAR=0.1, decimal=0.80) or better.
  • Subjects with a preoperative pharmacologically dilated pupil diameter of 6.5 mm or more.

Who cannot join

  • Currently pregnant or lactating.
  • Prisoners or young offenders in custody
  • Adults lacking capacity to consent for themselves
  • Phakic or aphakic status.
  • Narrow angle, i.e. < Schaefer grade 2
  • Pseudophakic patients with malpositioned, subluxated or unstable capsular fixated intraocular lens.
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  • Patients with a multifocal capsular bag fixated IOL.
  • Inability to achieve secure placement in the designated location e.g. due to absence of a secure peripheral anterior capsule, absence of intact zonules, or irregular anatomy of the ciliary sulcus.
  • Active ocular diseases (chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication, iris atrophy, severe zonulopathy, pigment dispersion syndrome).
  • Corneal abnormalities such as Unstable Keratoconus, irregular astigmatism.
  • Existing ocular conditions such as age-related macular degeneration (AMD) and other progressive retinal degenerations.
  • Any previous ocular co-morbidity including pseudoexfoliation, zonular weakness, pseudophakodonesis, complicated cataract surgery, narrow angle glaucoma or macular pathology, congenital eye abnormality, microphthalmia.
  • Any eye disease in which postoperative visual acuity is not expected to be better than 0.5 decimal (e.g. amblyopia, nystagmus, retinitis pigmentosa, aniridia, eccentric pupil)
  • Subjects with pathological pupil reactions.
  • Subjects with untreated posterior capsule opacification (PCO), which results in at least 1-line decrease in visual acuity and/or in loss of contrast sensitivity (CS).
  • Any systemic disease (e.g., Sjögren's syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with visual function and/or participation in the study.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with visual function.
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with visual function and/or participation in the study.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection, corneal decompensation) or any other ocular abnormality that may contraindicate the implantation of the supplementary IOL.
  • Any history or signs of a corneal inflammatory event, or any other ocular abnormality
  • Participation in any intraocular lens, contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  • Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial locations and contacts

4 sites in 4 countries.

Emese Dohovits contact

+36705292091

edohovits@medicontur.hu

4 sites in 4 countries

Belgium1 site, 1 recruiting

  • Medipolis Antwerp Private Clinic

    Antwerp, 2610

    Dr. Erik Mertens

    Dr. Erik Mertens

    Recruiting

Other trials in Belgium

France1 site, 1 recruiting

  • Institut Ophtalmologique de l'Ouest Jules Verne

    Nantes, 44300

    Dr Camille Bosc

    Dr Camille Bosc

    Recruiting

Other trials in France

Spain1 site, 1 recruiting

  • Hospital Vithas Almería

    Almería, 04120

    Dr. Joaquín Fernández

    Dr. Joaquín Fernández

    Recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting

  • Ayrshire Eye Clinic

    Ayr, Scotland, KA7 2SP

    Prof Sathish Srinivasan

    Prof Sathish Srinivasan

    Recruiting

Other trials in United Kingdom

About this study

The purpose of this prospective multicenter clinical study is to evaluate the visual and refractive outcomes and safety outcomes following bilateral implantation of trifocal and/or trifocal toric 1stQ AddOn (Medicontur) intraocular lenses (IOLs) to correct residual refractive errors, astigmatism, and presbyopia in previously pseudophakic eyes.

Being tested
supplementary intraocular lenses
Medical subject headings
Presbyopia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • supplementary intraocular lensesDevice

    Also called 1stQ AddOn

    Implantation of supplementary intraocular lenses into the ciliary sulcus in previously pseudophakic eyes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance Corrected Near Visual Acuity (DCNVA)

    Monocular and binocular DCNVA changes at 6 months after IOLs implantation in comparison to Baseline.

    Measured: 6 months

Secondary outcomes (6)

  1. Distance Corrected Near Visual Acuity (DCNVA)

    Monocular and binocular DCNVA changes after IOLs implantation in comparison to Baseline.

    Measured: 12 months

  2. Uncorrected Near Visual Acuity (UNVA)

    Monocular and binocular UNVA after IOLs implantation

    Measured: 12 months

  3. Uncorrected Intermediate Visual Acuity (UIVA)

    Monocular and binocular UIVA after IOLs implantation

    Measured: 12 months

  4. Distance Corrected Intermediate Visual Acuity (DCIVA)

    Monocular and binocular DCIVA after IOLs implantation

    Measured: 12 months

  5. Uncorrected Distance Visual Acuity (UDVA)

    Monocular and binocular UDVA after IOLs implantation

    Measured: 12 months

  6. Corrected Distance Visual Acuity (CDVA)

    Monocular and binocular CDVA after IOLs implantation

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start17 Oct 2022
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05596682
Sponsor's protocol ID
MC_AddOn_multi_2020
Status last verified
May 2023
First submitted
24 Oct 2022
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Presbyopia and Refractive Errors, run by Medicontur Medical Engineering Ltd at 4 sites in 4 countries.

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 13 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France, Spain, United Kingdom. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emese Dohovits (+36705292091, edohovits@medicontur.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance Corrected Near Visual Acuity (DCNVA) (time frame: 6 months). 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 NCT05596682.

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 2 Jun 2023.

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