Comparative Study of 3 Multifocal Intraocular Lenses in Murcia (C3M)

CRISTALENS

Status: Enrolling

Conditions: Cataract

Treatments: Device: intraocular lens implantation in cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT06323915

2020_03_C3M

Details and patient eligibility

About

The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve.

This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve.

The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.

Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

Full description

This trial is a single center, prospective, randomized (1:1), unblinded, controlled study conducted in Spain according to Art. 82 MDR (PMCF study).

The lead investigator at the Murcia Clínica Vista Ircovisión (Murcia Ircovision Eye Clinic) is Dr. Jerónimo LAJARA BLESA.

This study examines the visual performance of the three IOLs involved : ARTIS Symbiose (study lens) compared to FineVision (comparator), and Tecnis Synergy (comparator) in bilaterally implanted patients.

Due to the design of the ARTIS SYMBIOSE set of multifocal IOLs and the Tecnis Synergy multifocal IOL that target continuous sharp vision from far vision to near vision, this comparative trial is needed to evaluate if these approaches are able to achieve the enhancement in the patients' depth-of-field that has been reported with the FineVision trifocal IOL, which is considered as the "gold standard".

A total of approximately 84 patients will be included at 1 clinical center. Subjects participating in the study will attend a maximum of 5 study visits (1 preoperative, 1 operative and 3 postoperative visits) over a period of 12 months.

Only patients who have age-related cataracts will be included in the study. To participate in this study, patients must be at least 50 years old at the time of screening and maximum 85 years old. All patients who would like to take part in this study will receive a detailed study information by the investigator staff and a written informed form. Before a patient is admitted, he or she must sign a consent form.

The primary study endpoint is to compare the performance of 3 IOLs (FineVision, ARTIS SYMBIOSE, and Tecnis Synergy) through binocular distance-corrected defocus curve.

The entire study including data processing will be carried out in accordance with EN ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects, EN ISO 11979-7:2018: Clinical investigations of intraocular lenses for the correction of aphakia, EU MDR 2017/745, MEDDEV 2.7.1 rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MPDG:2020: Medical Device Law Implementation Act, as well as applicable local regulations and the Declaration of Helsinki.

Enrollment: 84 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 50 < Age < 85 years old
• Bilateral age-related cataract
• Signed informed consent of the study
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Qualify for bilateral implantation within 1 month
• No previous refractive or ocular surgery
• Need for IOL in this diopter range: 10 to 30 D
• Expected postoperative astigmatism ≤ 0.75 D
• Eye dryness ≤ 2 in dry eye severity grading

Non-inclusion criteria:

• Being under guardianship / curatorship
• Illiterate or not enough knowledge of Spanish language
• Acute or chronic disease or illness that would increase risk or confound study results found to be relevant by the investigators
• Pupil > 4mm or < 2mm in photopic conditions
• Occupation requiring night-time driving or any occupation incompatible with multifocality
• Amblyopia, strabismus, color blindness
• Extremely shallow anterior chamber
• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome).
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions).
• Irregular astigmatism, unstable cornea.

Exclusion criteria

• Inability to place the intraocular lens safely at the location planned
• Surgical complications (e.g. non-circular rhexis, oversized or undersized rhexis). Each patient with these intraoperative complications should not be implanted with the study IOL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

84 participants in 3 patient groups

FineVision

Active Comparator group

Description:

28 patients will be implanted bilaterally with Intensity FineVision (PhysIOL, Belgium) trifocal IOLs. The device is CE-marked and used according to the intended purpose.

Treatment:

Device: intraocular lens implantation in cataract surgery

Artis Symbiose

Active Comparator group

Description:

28 patients will be implanted bilaterally with Artis Symbiose (Cristalens Industrie, France) IOLs. The device is CE-marked and used according to the intended purpose.

Treatment:

Device: intraocular lens implantation in cataract surgery

Synergy

Active Comparator group

Description:

28 patients will be implanted bilaterally with Tecnis Synergy model ZFR00V (Johnson \& Johnson, USA) IOLs. The device is CE-marked and used according to the intended purpose.

Treatment:

Device: intraocular lens implantation in cataract surgery