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

Cataract Clinical Trial

— STATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05144308
• Other study ID #: JFO_2021_10
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: October 9, 2023

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 9, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschuld	Paris	Hôpital Fondation A. De Rothschild

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Johnson & Johnson

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean of the best monocular uncorrected distance visual acuity UDVA (logMAR) at 1 month post-operative		1 month
Primary	The mean of the best monocular corrected distance visual acuity (CDVA) (logMAR) preoperative (maximum 12 months before surgery)		12 months