Bilateral CataractFUSIONNCT03861351
Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION)
A study testing Mini WELL Toric Ready intraocular lens in people with Bilateral Cataract and Astigmatism, run by SIFI SpA at 4 sites in 3 countries.
Trial summary
This is a multicenter, non-comparative trial following participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Cataract, Astigmatism
- What is being tested?
- Mini WELL Toric Ready intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 19 Sep 2019to 30 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years of age or older at the time of surgery and diagnosed with bilateral cataracts;
- Planned bilateral cataract removal by phacoemulsification;
- Preoperative total corneal astigmatism of 0.89 - 2.91 D, measured by corneal topography in both operative eyes;
- IOL power and cylinder requirement calculated by the specific web-based Mini Toric Calculator within the following range:
- Cylinder of: 1.50 D to 4.00 D
- Spherical Equivalent of: 18.00 to 28.00 D
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- Willing and able to complete all required postoperative visits;
- Clear intraocular media other than cataract;
- Available for second-eye surgery within 2 weeks of the initial operation;
- Potential postoperative visual acuity of 0.3 logMAR in both eyes;
- Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.
Who cannot join
- Irregular / asymmetric astigmatism;
- Significant irregular corneal aberration as demonstrated by corneal topography;
- Keratopathy / Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomicosis and corneal plana;
- Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjuntivitis and keratouveitis;
- Subjects with diagnosed degenerative visual disorder (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.3 logMAR;
- Subjects who may have reasonably been expected to require a secondary surgical intervention at any time during the study (other than Nd:YAG capsulotomy);
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- Subjects in whom the intraocular lens might interfere with the ability to observe, diagnose or treat posterior segment conditions;
- Previous corneal refractive surgery;
- Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
- Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens, including but not limited to the following: pseudo-exfoliation syndrome, chronic uveitis, Marfan's Syndrome;
- Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag;
- Absence of adequate support for the lens from the posterior chamber or the zonule;
- Pupil abnormalities, including but not limited to the following: non-reactive, tonic pupils that do not dilatate under mesopic/scotopic conditions, abnormally shaped pupils or abnormally positioned pupils;
- Amblyopia;
- Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy);
- Proliferative diabetic retinopathy;
- Microphthalmos;
- Suspected microbial infection;
- Previous retinal detachment;
- Previous corneal transplant;
- Optic nerve atrophy;
- Extremely shallow anterior chamber, not due to swollen cataract;
- Recurrent severe anterior or posterior segment inflammation of unknown aetiology (e.g. chronic uveitis);
- Iris neovascularization;
- Glaucoma (uncontrolled or controlled with medication);
- Aniridia or iris atrophy;
- Severe dry eye;
- Use of any systemic or topical drug known to interfere with visual performance;
- Subjects with any systemic disease that could increase operative risk or confound the outcomes (e.g. uncontrolled diabetes);
- Use of contact lens within the last 30 days before the preoperative visit;
- Vulnerable subjects (children <18 years, people in guardianship or trusteeship or inability to give an informed consent);
- Pregnant or lactating or planning a pregnancy at the time of enrolment;
- Subjects with psychiatric disorders that could confound the outcomes;
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
- Intra-operative exclusion criteria:
- Irregularity and decentration of capsulorhexis;
- Other ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
- Significant vitreous loss;
- Significant anterior chamber hyphema;
- Uncontrollable intraocular pressure (IOP);
- Zonular or capsular rupture;
- Ciliary sulcus, Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
OFTALVIST CIO JEREZ Clínica Jerez (Cadiz)
Jerez de la Frontera, 11407
Hospital Universitario Quirónsalud Madrid
Madrid, 28223
France1 site
Service ophtalmologie Segment Antérieur- Hopital Pellegrin - CHU de Bordeaux
Bordeaux, 33076
Germany1 site
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
Heidelberg, 69120
About this study
Official title: A Multicenter, Non-controlled and Open-label Trial Following Subjects Implanted Bilaterally With the Toric Extended-depth-of-focus Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant
This is a multicenter, non-comparative trial following participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant.
The objective of the study is to evaluate the clinical performance of the Mini WELL Toric Ready intraocular lens (IOL), in particular, visual performance and rotational stability at 6 months following the second eye implantation in participants suffering from bilateral cataract with corneal astigmatism.
Read more
There are 2 hypotheses:
- Rotational Stability: the rotation of the Mini WELL Toric Ready IOL compared between Visit 0a (the day of surgery) and Visit 4 (120 180 days post-operative follow-up) shall be less than ±10° in 90% of the cases.
- Severe Visual Distortions: the rate of severe visual distortions for the Mini WELL Toric Ready IOL reported at 6 months postoperative will be less than 10 percents.
Read the detailed description
This is an interventional, multicenter, non-comparative post-marketing clinical investigation in participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant.
The objective of this study is to evaluate the clinical performance of the Mini WELL Toric Ready IOL, in particular, visual performance and rotational stability at 6 months following second eye implantation.
The first hypothesis raised for this study is related to rotational stability. The rotation of the Mini WELL Toric Ready IOL compared between Visit 0a (the day of surgery) and Visit 4 (120 180 days post-operative follow-up) shall be less than ±10° in 90% of the cases.
The second hypothesis is regarding severe visual distortions. The rate of severe visual distortions for the Mini WELL Toric Ready IOL reported 6 months post-operative will be less than 10 percents.
The study will involve 45participants in 3 countries in order to achieve a target number of 38 evaluable participants completing the study.
This clinical study is composed of 9 scheduled visits. Following completion of the Informed Consent process, a pre-operative examination will take place to determine each patient's eligibility. Eligible patients, who wish to continue with the study, will be invited to undergo their first surgical procedure within 30 days. They will be required to undergo their second surgical procedure within 2 weeks of the initial operation. They will also be required to return for additional post-operative follow-up visits, 1-2 days after each eye surgery, 7-14 days after each eye surgery, 30-60 days after bilateral surgery and 120-180 days after bilateral surgery.
- Conditions
- Bilateral Cataract, Astigmatism
- Being tested
- Mini WELL Toric Ready intraocular lens
- Keywords
- Cataract, Astigmatism
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini WELL Toric Ready intraocular lensDevice
The aim of cataract surgery is to remove the cloudy lens and replace it with the artificial intraocular lens called Mini WELL Toric Ready to correct presbyopia and to correct corneal astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Mini WELL Toric Ready intraocular lens | Experimental | Not described Receives: Device: Mini WELL Toric Ready intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular lens (IOL) rotation
To evaluate the rotational stability of Mini WELL Toric Ready IOL.
Measured: 6 months after second eye implant
Rate of severe visual distortions
To evaluate the visual performance of Mini WELL Toric Ready IOL.
Measured: 6 months after second eye implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start19 Sep 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral 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
- Not applicable
- Intervention model
- Single group
- Model description
- Men and women aged ≥ 18 years old suffering from bilateral cataract and astigmatism
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861351
- Sponsor's protocol ID
- PSM36
- Acronym
- FUSION
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-controlled and Open-label Trial Following Subjects Implanted Bilaterally With the Toric Extended-depth-of-focus Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant
- ClinicalTrials.gov ID
- NCT03861351
- Acronym / sponsor ID
- FUSION / PSM36
- Conditions
- Bilateral Cataract, Astigmatism
- Keywords
- Cataract, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Mar 2019 (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.
This is a multicenter, non-comparative trial following participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant.
The objective of the study is to evaluate the clinical performance of the Mini WELL Toric Ready intraocular lens (IOL), in particular, visual performance and rotational stability at 6 months following the second eye implantation in participants suffering from bilateral cataract with corneal astigmatism.
There are 2 hypotheses:
- Rotational Stability: the rotation of the Mini WELL Toric Ready IOL compared between Visit 0a (the day of surgery) and Visit 4 (120 180 days post-operative follow-up) shall be less than ±10° in 90% of the cases.
- Severe Visual Distortions: the rate of severe visual distortions for the Mini WELL Toric Ready IOL reported at 6 months postoperative will be less than 10 percents.
Detailed description
This is an interventional, multicenter, non-comparative post-marketing clinical investigation in participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant.
The objective of this study is to evaluate the clinical performance of the Mini WELL Toric Ready IOL, in particular, visual performance and rotational stability at 6 months following second eye implantation.
The first hypothesis raised for this study is related to rotational stability. The rotation of the Mini WELL Toric Ready IOL compared between Visit 0a (the day of surgery) and Visit 4 (120 180 days post-operative follow-up) shall be less than ±10° in 90% of the cases.
The second hypothesis is regarding severe visual distortions. The rate of severe visual distortions for the Mini WELL Toric Ready IOL reported 6 months post-operative will be less than 10 percents.
The study will involve 45participants in 3 countries in order to achieve a target number of 38 evaluable participants completing the study.
This clinical study is composed of 9 scheduled visits. Following completion of the Informed Consent process, a pre-operative examination will take place to determine each patient's eligibility. Eligible patients, who wish to continue with the study, will be invited to undergo their first surgical procedure within 30 days. They will be required to undergo their second surgical procedure within 2 weeks of the initial operation. They will also be required to return for additional post-operative follow-up visits, 1-2 days after each eye surgery, 7-14 days after each eye surgery, 30-60 days after bilateral surgery and 120-180 days after bilateral surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Men and women aged ≥ 18 years old suffering from bilateral cataract and astigmatism
| Arm | Type | Receives |
|---|---|---|
| Mini WELL Toric Ready intraocular lens | Experimental | Device: Mini WELL Toric Ready intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Eighteen years of age or older at the time of surgery and diagnosed with bilateral cataracts;
- Planned bilateral cataract removal by phacoemulsification;
- Preoperative total corneal astigmatism of 0.89 - 2.91 D, measured by corneal topography in both operative eyes;
- IOL power and cylinder requirement calculated by the specific web-based Mini Toric Calculator within the following range:
- Cylinder of: 1.50 D to 4.00 D
Key exclusion criteria (42 listed)
- Irregular / asymmetric astigmatism;
- Significant irregular corneal aberration as demonstrated by corneal topography;
- Keratopathy / Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomicosis and corneal plana;
- Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjuntivitis and keratouveitis;
- Subjects with diagnosed degenerative visual disorder (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.3 logMAR;
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 |
|---|---|---|
| Mini WELL Toric Ready intraocular lensThe aim of cataract surgery is to remove the cloudy lens and replace it with the artificial intraocular lens called Mini WELL Toric Ready to correct presbyopia and to correct corneal astigmatism. | Device | Mini WELL Toric Ready intraocular lens |
Primary outcome
Intraocular lens (IOL) rotation
Time frame: 6 months after second eye implant
To evaluate the rotational stability of Mini WELL Toric Ready IOL.
Rate of severe visual distortions
Time frame: 6 months after second eye implant
To evaluate the visual performance of Mini WELL Toric Ready IOL.
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 18 Apr 2023.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini WELL Toric Ready intraocular lens in people with Bilateral Cataract and Astigmatism, run by SIFI SpA at 4 sites in 3 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 11 inclusion and 42 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, France, Germany. 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?
Intraocular lens (IOL) rotation (time frame: 6 months after second eye implant). 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?
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 18 Apr 2023.