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

NCT ID: NCT05144308

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2023-10-09

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.

Conditions

Cataract; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Images of the operated eye (s)

Intervention Type: 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

Interventions

Images 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

Intervention Type: PROCEDURE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc FEBBRARO, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation A. de Rothschild

Locations

Hôpital Fondation A. de Rothschuld

Paris, Hôpital Fondation A. de Rothschild, France

Countries

France

Other Identifiers

JFO_2021_10

Identifier Type: -

Identifier Source: org_study_id