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

Not Applicable

Terminated

• Conditions: Cataract; Astigmatism
• Interventions: Procedure: Images of the operated eye (s)

• Registration Number: NCT05144308
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-03
• Study Start: 2021-12-07
• Primary Completion: 2023-06-22
• Status Verified: 2023-10
• Study Completion: 2023-10-09
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients operated with a TECNIS® Eyhance Toric II 1-piece posterior chamber lens	Images of the operated eye (s)	For at least one eye : Planned cataract surgery with placement of a TECNIS® Eyhance Toric II 1-piece posterior chamber lens

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschuld; 🇫🇷 Paris, Hôpital Fondation A. De Rothschild, France