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

NCT05596682 | Unknown

• 1 other identifier: MC_AddOn_multi_2020
• Study Type: observational
• Target: 75
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Presbyopia; Refractive Errors; Residual Astigmatism

Outcome Measures

Primary Outcomes (1)

• Distance Corrected Near Visual Acuity (DCNVA)

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

  6 months

Secondary Outcomes (6)

• Distance Corrected Near Visual Acuity (DCNVA)

  12 months

• Uncorrected Near Visual Acuity (UNVA)

  12 months

• Uncorrected Intermediate Visual Acuity (UIVA)

  12 months

• Distance Corrected Intermediate Visual Acuity (DCIVA)

  12 months

• Uncorrected Distance Visual Acuity (UDVA)

  12 months

Interventions

supplementary intraocular lenses DEVICE

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

Also known as: 1stQ AddOn

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Medicontur Medical Engineering Ltd: lead
• Medevise Consulting: collaborator

Study Sites (4)

Medipolis Antwerp Private Clinic

Antwerp, 2610, Belgium

RECRUITING

Institut Ophtalmologique de l'Ouest Jules Verne

Nantes, 44300, France

RECRUITING

Hospital Vithas Almería

Almería, 04120, Spain

RECRUITING

Ayrshire Eye Clinic

Ayr, Scotland, KA7 2SP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Prof Sathish Srinivasan

  Ayrshire Eye Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emese Dohovits

CONTACT

+36705292091; edohovits@medicontur.hu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: October 17, 2022
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

BE (1); FR (1); GB (1); ES (1)