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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Presbyopia; Residual Astigmatism
• Intervention / Treatment: Device: supplementary intraocular lenses

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Emese Dohovits; Phone Number: +36705292091; Email: edohovits@medicontur.hu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

1. The subject must read and sign the Informed Consent 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:

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 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.
17. Use of systemic medications (e.g., chronic steroid 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 investigational clinic (e.g., Investigator, Coordinator, Technician)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Corrected Near Visual Acuity (DCNVA)	Monocular and binocular DCNVA changes at 6 months after IOLs implantation in comparison to Baseline.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Corrected Near Visual Acuity (DCNVA)	Monocular and binocular DCNVA changes after IOLs implantation in comparison to Baseline.	12 months
Uncorrected Near Visual Acuity (UNVA)	Monocular and binocular UNVA after IOLs implantation	12 months
Uncorrected Intermediate Visual Acuity (UIVA)	Monocular and binocular UIVA after IOLs implantation	12 months
Distance Corrected Intermediate Visual Acuity (DCIVA)	Monocular and binocular DCIVA after IOLs implantation	12 months
Uncorrected Distance Visual Acuity (UDVA)	Monocular and binocular UDVA after IOLs implantation	12 months
Corrected Distance Visual Acuity (CDVA)	Monocular and binocular CDVA after IOLs implantation	12 months

Collaborators and Investigators

• Sponsor: Medicontur Medical Engineering Ltd
• Collaborators: Medevise Consulting
• Investigators: Principal Investigator: Prof Sathish Srinivasan, Ayrshire Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism
• Other Study ID Numbers: MC_AddOn_multi_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No