An interventional study of intraocular lens implantation in cataract surgery in Cataract, sponsored by Cristalens Industrie. Recruiting at 1 site in Spain. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Cristalens Industrie · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Cristalens Industrie is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Non-inclusion criteria:
Exclusion Criteria:
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
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
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
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.
Time frame: one month
Plan to share: No
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Cristalens Industrie