CataractDETPLUSTNCT05561478
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
An observational study of Cataract and Surgery, run by Cutting Edge SAS at 1 site in France.
Trial summary
Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Implantation of Synthesis Plus Toric IOL (investigational device)
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to Oct 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient requiring bilateral cataract surgery
Who may be able to join
- Patient older than 50 years old
- Patient requiring bilateral cataract surgery
- Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
- Expected postoperative astigmatism ≤ 0.75D diopter
- Corneal astigmatism ≤4D
- IOL spherical equivalent power requested between 15D and 25D
Show all 25Show fewer
- Signed informed consent
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Non inclusion Criteria:
- Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.
- Amblyopia with a visual acuity potential of less than 5/10
- IOL power needed outside the spherical equivalent diopter range: 15 to 25D
- Difficulty for cooperation (distance from their home, general health condition)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Irregular astigmatism
- Subject with postoperative astigmatism, expected > 0.75 D.
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- Patients with chronic uveitis
- Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions))
- Narrow anterior chambers (ACD ≤ 2.5 mm)
- Any corneal pathology potentially affecting the topography (eg. Keratoconus),
- Monophthalma patients
- Phacodonesis
Who cannot join
- Complicated surgery
- Inability to place the intraocular lens safely at the location planned
- Subjects with zonular laxity
- Postoperative endophthalmitis
Trial locations and contacts
1 site in 1 country.
About this study
Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.
- Being tested
- Implantation of Synthesis Plus IOL (control device), Implantation of Synthesis Plus Toric IOL (investigational device)
- 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 Synthesis Plus IOL (control device)Device
Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
Implantation of Synthesis Plus Toric IOL (investigational device)Device
Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.
| Study group | Role | What they receive |
|---|---|---|
| Test device (Synthesis Plus Toric) | Requiring bilateral cataract surgery with pre-existing astigmatism Receives: Device: Implantation of Synthesis Plus Toric IOL (investigational device) | |
| Control device (Synthesis Plus) | Requiring bilateral cataract surgery Receives: Device: Implantation of Synthesis Plus IOL (control device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCIVA at 66 cm
The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS
Measured: 1 month
Secondary outcomes (8)
Monocular UDVA
distance
Measured: 1 month
Monocular BCDVA
distance
Measured: 1 month
Monocular UIVA
66 cm
Measured: 1 month
Monocular DCIVA
66 cm
Measured: 1 month
Refraction
subjective
Measured: 1 month
Potential complications
postoperative
Measured: 1 month
Rotational stability
in degrees
Measured: Peroperatively, day 0, Month 1
Subjective quality of vision
PROM
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start10 Oct 2022
- Primary completionAug 2025 (estimated)
- Study completionOct 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutting Edge SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Dethinne, MD, Principal investigator, Visis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561478
- Sponsor's protocol ID
- 2021-A02415-36
- Acronym
- DETPLUST
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2022
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
- ClinicalTrials.gov ID
- NCT05561478
- Acronym / sponsor ID
- DETPLUST / 2021-A02415-36
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cutting Edge SASIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Sep 2022 (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.
Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test device (Synthesis Plus Toric) | – | Device: Implantation of Synthesis Plus Toric IOL (investigational device)Requiring bilateral cataract surgery with pre-existing astigmatism |
| Control device (Synthesis Plus) | – | Device: Implantation of Synthesis Plus IOL (control device)Requiring bilateral cataract surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient requiring bilateral cataract surgery
Key inclusion criteria (25 listed)
- Patient older than 50 years old
- Patient requiring bilateral cataract surgery
- Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
- Expected postoperative astigmatism ≤ 0.75D diopter
- Corneal astigmatism ≤4D
Key exclusion criteria (4 listed)
- Complicated surgery
- Inability to place the intraocular lens safely at the location planned
- Subjects with zonular laxity
- Postoperative endophthalmitis
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 Synthesis Plus IOL (control device)Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients. | Device | Control device (Synthesis Plus) |
| Implantation of Synthesis Plus Toric IOL (investigational device)Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism. | Device | Test device (Synthesis Plus Toric) |
Primary outcome
DCIVA at 66 cm
Time frame: 1 month
The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS
8 secondary outcomes
Monocular UDVA
Time frame: 1 month
Monocular BCDVA
Time frame: 1 month
Monocular UIVA
Time frame: 1 month
Monocular DCIVA
Time frame: 1 month
Refraction
Time frame: 1 month
Potential complications
Time frame: 1 month
Rotational stability
Time frame: Peroperatively, day 0, Month 1
Subjective quality of vision
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
Boris Dethinne, MD principal investigator
Visis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Surgery, run by Cutting Edge SAS at 1 site 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 25 inclusion and 4 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 11 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Line Bettinelli, OD (0619530701, line.bettinelli@cutting-edge.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCIVA at 66 cm (time frame: 1 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 11 Feb 2025.