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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: intraocular lens implantation in cataract surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie Lebeau; Phone Number: +33 (0)2 96 48 92 92; Email: s.lebeau.ci@cristalens.fr

Study Locations

• Spain
  • Murcia, Spain, 30008
    • Recruiting
    • Vista Clinic Ircovision Murcia
    • Contact: Juan Zapata; Phone Number: +34 968 27 17 35; Email: juanf.zapata.diaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FineVision; 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.	Device: intraocular lens implantation in cataract surgery; Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery
Active Comparator: Artis Symbiose; 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.	Device: intraocular lens implantation in cataract surgery; Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery
Active Comparator: Synergy; 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.	Device: intraocular lens implantation in cataract surgery; Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
defocus curve comparison	The defocus curves will be carried out from + 1.00 D to - 4.00D with measures of binocular visual acuity in LogMAR with ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 month. The primary endpoint is visual acuity assessed by depth of field at 0 logMAR.	one month

Collaborators and Investigators

• Sponsor: Cristalens Industrie

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): September 20, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2020_03_C3M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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