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NCT05144308: STATE

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

Terminated NA Last updated 23 October 2023
What this trial tests

NA trial testing Images of the operated eye (s) in Cataract in 13 participants. Terminated before completion.

Timeline
7 December 2021
Primary endpoint
22 June 2023
9 October 2023

Quick facts

Lead sponsorFondation Ophtalmologique Adolphe de Rothschild
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment13
Start date7 December 2021
Primary completion22 June 2023
Estimated completion9 October 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

18 and older, any sex, with Cataract or Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Cataract

Currently open trials in the same condition.

Other Fondation Ophtalmologique Adolphe de Rothschild trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05144308.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing