CataractC3MNCT06323915
Comparative Study of 3 Multifocal Intraocular Lenses in Murcia
A study testing intraocular lens implantation in cataract surgery in people with Cataract, run by Cristalens Industrie at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- intraocular lens implantation in cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2021to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vista Clinic Ircovision Murcia
Murcia, 30008
Juan Zapata, +34 968 27 17 35, juanf.zapata.diaz@gmail.com
About this study
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- intraocular lens implantation in cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lens implantation in cataract surgeryDevice
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
| Study group | Role | What they receive |
|---|---|---|
| FineVision | Active comparator | 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. Receives: Device: intraocular lens implantation in cataract surgery |
| Artis Symbiose | Active comparator | 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. Receives: Device: intraocular lens implantation in cataract surgery |
| Synergy | Active comparator | 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. Receives: Device: intraocular lens implantation in cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start20 Apr 2021
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristalens Industrie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323915
- Sponsor's protocol ID
- 2020_03_C3M
- Acronym
- C3M
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 3 Multifocal Intraocular Lenses in Murcia
- ClinicalTrials.gov ID
- NCT06323915
- Acronym / sponsor ID
- C3M / 2020_03_C3M
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cristalens IndustrieIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FineVision | Active comparator | Device: intraocular lens implantation in cataract surgery28 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 comparator | Device: intraocular lens implantation in cataract surgery28 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 comparator | Device: intraocular lens implantation in cataract surgery28 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraocular lens implantation in cataract surgeryImplantation 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 | Device | Artis Symbiose, FineVision, Synergy |
Primary outcome
defocus curve comparison
Time frame: one month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular lens implantation in cataract surgery in people with Cataract, run by Cristalens Industrie at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Lebeau (+33 (0)2 96 48 92 92, s.lebeau.ci@cristalens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
defocus curve comparison (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.