NCT05392998

Brief Summary

Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning. Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

May 23, 2022

Results QC Date

August 30, 2023

Last Update Submit

August 30, 2023

Conditions

Lenses, Intraocular

Keywords

extended depth of focus intraocular lensastigmatism

Outcome Measures

Primary Outcomes (3)

  • Distance Against the Rule Astimatism

    Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0\*, taking as a reference the subjects' axis

    Three months after surgery

  • Distance Oblique Astigmatism

    Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45\*, taking as a reference the subjects' axis

    Three months after surgery

  • Distance With the Rule Astigmatism

    Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90\*, taking as a reference the subjects' axis

    Three months after surgery

Study Arms (1)

Vivity patients

The study will include patients \>40 years old that undergo routine cataract surgery and implantation of Vivity ®. Exclusion criteria include corneal astigmatism ≥1.0 diopters (D ), amblyopia, previous ocular surgery and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative best distance corrected visual acuity (BDCVA) \< 20/20 and with postoperative refractive astigmatism \> 0.50D will be also excluded . Inclusion and exclusion criteria will be assessed by an ophthalmologic examination including refraction, screening for ocular conditions and/or systemic diseases, slit-lamp biomicroscopy and fundus examination.

Device: Cataract surgery with Vivity intraocular lens implantation

Interventions

Cataract surgery with Vivity intraocular lens implantationDEVICE

Cataract surgery with Vivity intraocular lens implantation

Vivity patients

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing bilateral cataract surgery with bilateral Vivity intraocular lens implantation, with no other ocular diseases and no complications

You may qualify if:

  • Patients \>40 years old that undergo routine cataract surgery
  • Bilateral implantation of Vivity ® IOL

You may not qualify if:

  • Corneal astigmatism ≥1.0 diopters (D )
  • Amblyopia
  • Previous ocular surgery
  • Presence of ocular pathologies
  • Abnormal iris
  • Patients with intra- or postoperative complications
  • Postoperative best distance corrected visual acuity (BDCVA) \< 20/20
  • Postoperative refractive astigmatism \> 0.50D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Rementería

Madrid, 28010, Spain

Location

MeSH Terms

Conditions

Astigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Inés Contreras
Organization
Clínica Rementería
contreras@clinicarementeria.es
34913083838

Study Officials

  • Laureano Rementeria-Capelo, MD

    Clínica Rementería

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

June 16, 2021

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

March 18, 2024

Results First Posted

March 18, 2024

Record last verified: 2023-08

Locations

ES(1)