NCT05144308

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

December 7, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

November 10, 2021

Last Update Submit

October 18, 2023

Conditions

CataractAstigmatism

Keywords

TECNIS® Eyhance Toric II 1-piece posterior chamber lens

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

EXPERIMENTAL

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

Procedure: Images of the operated eye (s)

Interventions

Images of the operated eye (s)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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, Hôpital Fondation A. de Rothschild, 75019, France

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Jean-Luc FEBBRARO, MD

    Hôpital Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-center prospective cohort study
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 3, 2021

Study Start

December 7, 2021

Primary Completion

June 22, 2023

Study Completion

October 9, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

FR(1)