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

Study Overview
=================
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.

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

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Procedure: Images of the operated eye (s)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens<br>For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens | Procedure: Images of the operated eye (s)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TECNIS® Eyhance Toric II 1-piece posterior chamber lens