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Clinical Trials/NCT05144308
NCT05144308
Terminated
Not Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country13 target enrollmentDecember 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
13
Locations
1
Primary Endpoint
The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative
Status
Terminated
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 7, 2021
End Date
October 9, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative

Time Frame: 1 month

The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)

Time Frame: 12 months

Study Sites (1)

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