Comparative Study of 3 Multifocal Intraocular Lenses in Murcia
C3M
1 other identifier
interventional
84
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2021
CompletedFirst Submitted
Initial submission to the registry
March 15, 2024
CompletedFirst Posted
Study publicly available on registry
March 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedMarch 21, 2024
March 1, 2024
4.2 years
March 15, 2024
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
FineVision
ACTIVE COMPARATOR28 patients will be implanted bilaterally with Intensity FineVision (PhysIOL, Belgium) trifocal IOLs. The device is CE-marked and used according to the intended purpose.
Artis Symbiose
ACTIVE COMPARATOR28 patients will be implanted bilaterally with Artis Symbiose (Cristalens Industrie, France) IOLs. The device is CE-marked and used according to the intended purpose.
Synergy
ACTIVE COMPARATOR28 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- \< 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
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vista Clinic Ircovision Murcia
Murcia, 30008, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
March 21, 2024
Study Start
April 20, 2021
Primary Completion
June 20, 2025
Study Completion
September 20, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share