CataractSTATENCT05144308
Assessment of Visual and Refractive Results and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery
A study testing Images of the operated eye (s) in people with Cataract and Astigmatism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Images of the operated eye (s)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2021to 9 Oct 2023
- 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
- Aged ≥ 18 years
- Patients scheduled for bilateral cataract surgery
- For at least one eye :
- Cataract surgery clinically indicated
- Corneal astigmatism ≥ 1 D
- Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens
Show all 14Show fewer
- Non inclusion criteria
- Pregnant or breast-feeding women
- In the eye with planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens:
- Irregular astigmatism (keratoconus suspicion)
- Corneal scaring in visual axis
- Retinal impairment that may limit visual recovery (macular degeneration, history of retinal detachment, etc.)
- Visually impaired eye since childhood that cannot be improved despite correction of the refractive disorder
- Any other ophthalmic disease inducing visual impairment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation A. de Rothschuld
Paris, Hôpital Fondation A. de Rothschild, 75019
About this study
Official title: Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.
The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson \& Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.
No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.
- Conditions
- Cataract, Astigmatism
- Being tested
- Images of the operated eye (s)
- Keywords
- TECNIS® Eyhance Toric II 1-piece posterior chamber lens
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Images of the operated eye (s)Procedure or surgery
Through the operating microscope or a slit lamp, dilated pupil. Taken on the day of surgery (D0) and at 1 week, 1 month and 3 months post-op
| Study group | Role | What they receive |
|---|---|---|
| Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens | Experimental | For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens Receives: Procedure: Images of the operated eye (s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
Measured: 1 month
The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start7 Dec 2021
- Primary completion22 Jun 2023
- Study completion9 Oct 2023
Why it stopped: Sponsor-investigator agreement
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Single-center prospective cohort study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FEBBRARO, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144308
- Sponsor's protocol ID
- JFO_2021_10
- Acronym
- STATE
- Status last verified
- Oct 2023
- First submitted
- 10 Nov 2021
- Last updated
- 23 Oct 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE
- ClinicalTrials.gov ID
- NCT05144308
- Acronym / sponsor ID
- STATE / JFO_2021_10
- Conditions
- Cataract, Astigmatism
- Keywords
- TECNIS® Eyhance Toric II 1-piece posterior chamber lens
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor-investigator agreement
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Johnson & Johnson
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 3 Dec 2021 (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.
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.
The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson \& Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.
No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens | Experimental | Procedure: Images of the operated eye (s)For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥ 18 years
- Patients scheduled for bilateral cataract surgery
- For at least one eye :
- Non inclusion criteria
- Pregnant or breast-feeding women
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Images of the operated eye (s)Through the operating microscope or a slit lamp, dilated pupil. Taken on the day of surgery (D0) and at 1 week, 1 month and 3 months post-op | Procedure or surgery | Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens |
Primary outcome
The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
Time frame: 1 month
The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Sponsor-investigator agreement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Jean-Luc FEBBRARO, MD principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Images of the operated eye (s) in people with Cataract and Astigmatism, run by Fondation Ophtalmologique Adolphe de Rothschild 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 14 inclusion and 0 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 23 Oct 2023. 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?
The study was stopped early (reason given: Sponsor-investigator agreement). 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?
The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative (time frame: 1 month). 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 23 Oct 2023.