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RecruitingNCT05596682Updated Jun 2, 2023

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 in Presbyopia, Refractive Errors and Residual Astigmatism, sponsored by Medicontur Medical Engineering Ltd. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-02.

Sponsored by Medicontur Medical Engineering Ltd · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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 previously pseudophakic eyes.

02

Conditions studied

  • Presbyopia
  • Refractive Errors
  • Residual Astigmatism
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 75 is below the median of 88 across 52 observational studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Medicontur Medical Engineering Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject must read and sign the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Adult males or females above 18 years of age.
  4. No other ocular co -morbidity (i.e. no history of ocular surface disease, severe dry eye, glaucoma, retinal or macular pathology)
  5. Pseudophakia.
  6. Uncomplicated cataract surgery or clear lens extraction followed by an uneventful recovery period of at least 3-months.
  7. Stable primary IOL located in the capsular bag.
  8. 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]).
  9. Subjects with residual refractive error that is suitable for correction with a secondary add-on IOL.
  10. Subjects, who have stable post-operative refraction at month two following uncomplicated primary lens surgery.
  11. Subjects with myopia of not more than 6.0 diopters.
  12. Subjects with monocular corrected distance visual acuity (CDVA) of Snellen 6/7.5 (20/25; LogMAR=0.1, decimal=0.80) or better.
  13. Subjects with a preoperative pharmacologically dilated pupil diameter of 6.5 mm or more.

Exclusion criteria

Exclusion Criteria:

  1. Currently pregnant or lactating.
  2. Prisoners or young offenders in custody
  3. Adults lacking capacity to consent for themselves
  4. Phakic or aphakic status.
  5. Narrow angle, i.e. \< Schaefer grade 2
  6. Pseudophakic patients with malpositioned, subluxated or unstable capsular fixated intraocular lens.
  7. Patients with a multifocal capsular bag fixated IOL.
  8. 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.
  9. Active ocular diseases (chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication, iris atrophy, severe zonulopathy, pigment dispersion syndrome).
  10. Corneal abnormalities such as Unstable Keratoconus, irregular astigmatism.
  11. Existing ocular conditions such as age-related macular degeneration (AMD) and other progressive retinal degenerations.
  12. Any previous ocular co-morbidity including pseudoexfoliation, zonular weakness, pseudophakodonesis, complicated cataract surgery, narrow angle glaucoma or macular pathology, congenital eye abnormality, microphthalmia.
  13. 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)
  14. Subjects with pathological pupil reactions.
  15. 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).
  16. Any systemic disease (e.g., Sjögren's syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious diseases (e.g., ), 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.
  17. Use of systemic medications (e.g., chronic use) that are known to interfere with visual function.
  18. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with visual function and/or participation in the study.
  19. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  20. 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.
  21. Any history or signs of a corneal inflammatory event, or any other ocular abnormality
  22. Participation in any intraocular lens, contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  23. Employee, relative or friends of employees of any ophthalmic company, or clinic (e.g., Investigator, Coordinator, Technician)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Interventions

  • Devicesupplementary intraocular lenses

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

    Also known as: 1stQ AddOn

06

What researchers measure

Primary outcomes

  1. Distance Corrected Near Visual Acuity (DCNVA)

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

    Time frame: 6 months

Secondary outcomes

  1. Distance Corrected Near Visual Acuity (DCNVA)

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

    Time frame: 12 months

  2. Uncorrected Near Visual Acuity (UNVA)

    Monocular and binocular UNVA after IOLs implantation

    Time frame: 12 months

  3. Uncorrected Intermediate Visual Acuity (UIVA)

    Monocular and binocular UIVA after IOLs implantation

    Time frame: 12 months

  4. Distance Corrected Intermediate Visual Acuity (DCIVA)

    Monocular and binocular DCIVA after IOLs implantation

    Time frame: 12 months

  5. Uncorrected Distance Visual Acuity (UDVA)

    Monocular and binocular UDVA after IOLs implantation

    Time frame: 12 months

  6. Corrected Distance Visual Acuity (CDVA)

    Monocular and binocular CDVA after IOLs implantation

    Time frame: 12 months

07

Study locations

4 of 4 sites recruiting
  • Medipolis Antwerp Private Clinic
    Antwerpen, 2610, Belgium
    Recruiting
    • Dr. Erik Mertens · Contact
    • Dr. Erik Mertens · Principal investigator
  • Institut Ophtalmologique de l'Ouest Jules Verne
    Nantes, 44300, France
    Recruiting
    • Dr Camille Bosc · Contact
    • Dr Camille Bosc · Principal investigator
  • Hospital Vithas Almería
    Almería, 04120, Spain
    Recruiting
    • Dr. Joaquín Fernández · Contact
    • Dr. Joaquín Fernández · Principal investigator
  • Ayrshire Eye Clinic
    Ayr, Scotland KA7 2SP, United Kingdom
    Recruiting
    • Prof Sathish Srinivasan · Contact
    • Prof Sathish Srinivasan · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05596682
Lead sponsor
Medicontur Medical Engineering Ltd
Collaborators
Medevise Consulting
Responsible party
Sponsor
First posted
Oct 27, 2022
Start date
Oct 17, 2022
Primary completion
May 31, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Jun 2, 2023

Study contacts

Emese Dohovits
Contact
edohovits@medicontur.hu
+36705292091
Prof Sathish Srinivasan
principal investigator · Ayrshire Eye Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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