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Sponsor-investigator agreement
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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Images of the operated eye (s) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative | 1 month | |
| The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery) | 12 months |
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Inclusion criteria
Aged ≥ 18 years
Patients scheduled for bilateral cataract surgery
For at least one eye :
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc FEBBRARO, MD | Hôpital Fondation A. de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation A. de Rothschuld | Paris | Hôpital Fondation A. de Rothschild | 75019 | France |
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Single-center prospective cohort study
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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