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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05144308

Acronym

STATE

Enrollment

Registered

2021-12-03

Start date

2021-12-07

Completion date

2023-10-09

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract

Keywords

TECNIS® Eyhance Toric II 1-piece posterior chamber lens

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.

Interventions

PROCEDUREImages 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single-center prospective cohort study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026