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 (STATE)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Cataract; Astigmatism

Treatments: Procedure: Images of the operated eye (s)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT05144308

JFO_2021_10

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens

Experimental group

Description:

For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens

Treatment:

Procedure: Images of the operated eye (s)