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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596682
• Other study ID #: MC_AddOn_multi_2020
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: Emese Dohovits
• Phone: +36705292091
• Email: edohovits[@]medicontur.hu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 previously pseudophakic eyes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism
• Presbyopia
• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
Belgium	Medipolis Antwerp Private Clinic	Antwerpen
France	Institut Ophtalmologique de l'Ouest Jules Verne	Nantes
Spain	Hospital Vithas Almería	Almería
United Kingdom	Ayrshire Eye Clinic	Ayr	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd	Medevise Consulting

Countries where clinical trial is conducted

Belgium,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Corrected Near Visual Acuity (DCNVA)	Monocular and binocular DCNVA changes at 6 months after IOLs implantation in comparison to Baseline.	6 months
Secondary	Distance Corrected Near Visual Acuity (DCNVA)	Monocular and binocular DCNVA changes after IOLs implantation in comparison to Baseline.	12 months
Secondary	Uncorrected Near Visual Acuity (UNVA)	Monocular and binocular UNVA after IOLs implantation	12 months
Secondary	Uncorrected Intermediate Visual Acuity (UIVA)	Monocular and binocular UIVA after IOLs implantation	12 months
Secondary	Distance Corrected Intermediate Visual Acuity (DCIVA)	Monocular and binocular DCIVA after IOLs implantation	12 months
Secondary	Uncorrected Distance Visual Acuity (UDVA)	Monocular and binocular UDVA after IOLs implantation	12 months
Secondary	Corrected Distance Visual Acuity (CDVA)	Monocular and binocular CDVA after IOLs implantation	12 months