CataractNCT04465344
Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
A study testing Implantation of trifocal IOL, Isatis TF (device under investigation) in people with Cataract and Lens Opacities, run by Cutting Edge SAS at 7 sites in 2 countries.
Trial summary
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities
- What is being tested?
- Implantation of trifocal IOL, Isatis TF (device under investigation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 31 May 2021to 27 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically documented age-related cataract in both eyes with no comorbidity;
- Calculated IOL power is within the range of the investigational IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
- Regular corneal astigmatism (measured by topographer)
- Astigmatism ≤1.0 D (measured by an automatic keratometer)
- Clear intraocular media other than cataract;
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- Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group);
- Signed informed consent.
Who cannot join
- Age of patient < 50 years;
- Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
- Irregular astigmatism (measured by topographer);
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
- Subjects with AMD suspicious eyes as determined by OCT examination;
Show all 21Show fewer
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
- Ocular hypertension, suspicious glaucoma or glaucoma;
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
- Expected complicated surgery;
- Ocular surface disease (clinical symptoms or keratitis);
- Pregnancy or lactation;
- Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
- Concurrent participation in another drug or device investigation.
- In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:
- zonular instability;
- need for iris manipulation;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Spain4 sites
Hospital Donostia
Donostia / San Sebastian, 20014
Oftalvist Madrid
Madrid, 28006
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Miguel Servet
Zaragoza, 50009
Czechia3 sites
Gemini Eye Clinic Ostrava
Ostrava, 700 30
Gemini Eye Clinic Praha-Krc
Prague, 140 00
Gemini Eye Clinic Zlín
Zlín, 760 01
About this study
Official title: Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
Read the detailed description
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.
The investigational device, Control lens and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The study will be carried out in up to five clinical centers in Spain.
The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.
The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.
In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically.
Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.
- Conditions
- Cataract, Lens Opacities
- Being tested
- Implantation of trifocal IOL, Isatis TF (device under investigation), Implantation of monofocal IOL, Isatis (control device)
- Keywords
- Intraocular Lens, IOL, hydrophobic, trifocal
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of trifocal IOL, Isatis TF (device under investigation)Device
Patients will be implanted with study IOL in both eyes
Implantation of monofocal IOL, Isatis (control device)Device
Patients will be implanted with Control IOL in both eyes
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | Experimental arm: Trifocal intraocular lens Isatis TF Receives: Device: Implantation of trifocal IOL, Isatis TF (device under investigation) |
| IOL implantation active comparator | Active comparator | Comparator arm: Monofocal intraocular lens Isatis Receives: Device: Implantation of monofocal IOL, Isatis (control device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Rates of Adverse Events
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Measured: 120-180 days postoperative
Primary Performance Endpoint: Best Corrected Distance Visual Acuity
The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
Measured: 120-180 days postoperative
Secondary outcomes (3)
Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Measured: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.
Measured: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.
Measured: 120-180 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start31 May 2021
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutting Edge SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465344
- Sponsor's protocol ID
- CE2001
- Status last verified
- Sep 2024
- First submitted
- 7 Jul 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
PubMed 20505205Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
PubMed 28341605Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
PubMed 19251145
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT04465344
- Acronym / sponsor ID
- CE2001
- Conditions
- Cataract, Lens Opacities
- Keywords
- Intraocular Lens, IOL, hydrophobic, trifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Cutting Edge SASIndustry (pharma, biotech, devices)
- Collaborators
- targomedGmbH
- Study start
- 31 May 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 10 Jul 2020 (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 study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
Detailed description
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.
The investigational device, Control lens and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.
The study will be carried out in up to five clinical centers in Spain.
The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.
The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.
In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically.
Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: Implantation of trifocal IOL, Isatis TF (device under investigation)Experimental arm: Trifocal intraocular lens Isatis TF |
| IOL implantation active comparator | Active comparator | Device: Implantation of monofocal IOL, Isatis (control device)Comparator arm: Monofocal intraocular lens Isatis |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinically documented age-related cataract in both eyes with no comorbidity;
- Calculated IOL power is within the range of the investigational IOLs;
- Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
- Regular corneal astigmatism (measured by topographer)
- Astigmatism ≤1.0 D (measured by an automatic keratometer)
Key exclusion criteria (21 listed)
- Age of patient < 50 years;
- Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
- Irregular astigmatism (measured by topographer);
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
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 |
|---|---|---|
| Implantation of trifocal IOL, Isatis TF (device under investigation)Patients will be implanted with study IOL in both eyes | Device | IOL implantation experimental |
| Implantation of monofocal IOL, Isatis (control device)Patients will be implanted with Control IOL in both eyes | Device | IOL implantation active comparator |
Primary outcome
Primary Safety Endpoint: Rates of Adverse Events
Time frame: 120-180 days postoperative
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Primary Performance Endpoint: Best Corrected Distance Visual Acuity
Time frame: 120-180 days postoperative
The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
3 secondary outcomes
Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
Time frame: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 120-180 days postoperative
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 120-180 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 20505205McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
- Background: PubMed 28341605Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
- Background: PubMed 19251145Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of trifocal IOL, Isatis TF (device under investigation) in people with Cataract and Lens Opacities, run by Cutting Edge SAS at 7 sites in 2 countries.
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 9 inclusion and 21 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: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Rates of Adverse Events (time frame: 120-180 days postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04465344, which also lists 3 linked publications.
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 12 Feb 2025.