CataractNCT03060954
Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery
A study testing MINI WELL READY ® and FINE VISION® in people with Cataract and Presbyopia, run by SIFI SpA at 2 sites in France.
Trial summary
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- MINI WELL READY ® and FINE VISION®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Feb 2019to 5 Mar 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Bilateral cataract surgery required, no other ocular comorbidities
- Healthy corneas, not treated surgically
- Available for second-eye surgery within 1 week of the initial operation
- Spherical refraction between -8.00D and +6.00D
- Willing to adhere to the study visit schedule
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- Normal anterior and posterior segments
- Clear intraocular media - other than cataract
- To benefit from a social security system before being enrolled
- Written informed consent consistent with local regulation research in human subjects
Who cannot join
- Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
- Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
- Expected to require retinal laser treatment
- A history of retinal detachment or predisposition for such disorder
- Psudoexfoliation
- Abnormal pupil size and position
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- Pupil size > 7 mm under mesopic condition
- Use of contact lenses 30 days before the preoperative visit
- Corneal warpage (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
- Corneal astigmatism greater than 0.75D
- Zonular laxicity
- Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag
- Microphthalmus
- Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch's endothelial dystrophy)
- Suspected microbial infection
- Irregularities and capsulorexis decentralization
- Surgical difficulties that may increase the risk of complications such as persistent bleeding, significant iris damage, an uncontrollable intraocular hypertonia, or damage due to significant vitreous loss
- Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat diseases of the posterior segment
- Patients in whom neither the posterior capsule nor the zonula can provide adequate support to the lens
- Subjects with any systemic disease that could increase operative risk or confound the outcome
- Pregnant or lactating or planning a pregnancy at the time of enrolment
- Vulnerable subjects (children <18 years, people in guardianship or trusteeship or inability to give an informed consent)
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
Read the detailed description
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
- Conditions
- Cataract, Presbyopia
- Being tested
- MINI WELL READY ®, FINE VISION®
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINI WELL READY ®Device
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
FINE VISION®Device
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
| Study group | Role | What they receive |
|---|---|---|
| MINI WELL READY ® | Experimental | BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY Receives: Device: MINI WELL READY ® |
| FineVision ® | Other | FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY Receives: Device: FINE VISION® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defocus curve - binocular
Defocus curve assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start10 Feb 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Gianluca Stivale, Study director, SIFI SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060954
- Sponsor's protocol ID
- PSM29
- Status last verified
- Sep 2020
- First submitted
- 18 Feb 2017
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.
- ClinicalTrials.gov ID
- NCT03060954
- Acronym / sponsor ID
- PSM29
- Conditions
- Cataract, Presbyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 23 Feb 2017 (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.
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
Detailed description
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINI WELL READY ® | Experimental | Device: MINI WELL READY ®BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY |
| FineVision ® | Other | Device: FINE VISION®FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Bilateral cataract surgery required, no other ocular comorbidities
- Healthy corneas, not treated surgically
- Available for second-eye surgery within 1 week of the initial operation
- Spherical refraction between -8.00D and +6.00D
Key exclusion criteria (23 listed)
- Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
- Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
- Expected to require retinal laser treatment
- A history of retinal detachment or predisposition for such disorder
- Psudoexfoliation
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 READY ®BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY | Device | MINI WELL READY ® |
| FINE VISION®FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY | Device | FineVision ® |
Primary outcome
Defocus curve - binocular
Time frame: 6 months
Defocus curve assessment
Results and safety
The study was stopped early (reason given: The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
Gianluca Stivale study director
SIFI SpA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINI WELL READY ® and FINE VISION® in people with Cataract and Presbyopia, run by SIFI SpA at 2 sites in France.
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 10 inclusion and 23 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: stopped early, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.). Results are not available in the source record.
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?
Defocus curve - binocular (time frame: 6 months). 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 3 Sep 2020.