Clinical trial NCT05144308: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Astigmatism
Keywords: TECNIS® Eyhance Toric II 1-piece posterior chamber lens
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Johnson & Johnson
First posted: 2021-12-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center prospective cohort study
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion criteria

* 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

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

Primary outcomes:
measure: The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
timeFrame: 1 month
measure: The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
state: Hôpital Fondation A. De Rothschild
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Jean-Luc FEBBRARO, MD
role: PRINCIPAL_INVESTIGATOR
References: