Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

NCT05488769 | Terminated FDA Device

• 1 other identifier: TN-22-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Binocular distance-corrected visual acuity at distance (6m)

  3 months postoperative

• Binocular distance-corrected visual acuity at intermediate (66cm)

  3 months postoperative

Secondary Outcomes (2)

• Percentage of eyes with absolute prediction error less than or equal to 0.50D

  3 months postoperative

• Percentage of eyes with refractive astigmatism less than or equal to 0.50 D

  3 months postoperative

Other Outcomes (3)

• Satisfaction questionnaire

  3 months postoperative

• Visual disturbances questionnaire

  3 months postoperative

• Binocular uncorrected and distance-corrected visual acuity at near (40cm)

  3 months postoperative

Study Arms (1)

Clareon Vivity extended depth of focus (EDOF) intraocular lens

Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens

Interventions

Clareon Vivity extended depth of focus (EDOF) intraocular lens DEVICE

Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens

Clareon Vivity extended depth of focus (EDOF) intraocular lens

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.

You may not qualify if:

• Previous ocular or refractive surgery
• Ocular surface disease/Dry Eye Disease
• Intraoperative complications during procedure
• Glaucoma, including well-controlled
• Any disorders that reduce binocular vision (ie Strabismus)
• Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)
• The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
• Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Sponsors & Collaborators

• Thomas Nagy: lead
• Sengi: collaborator

Study Sites (1)

Vision North Eye Centre

Terrace, British Columbia, V8G 1V7, Canada

Location

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Officials

• Thomas Nagy, MD

  Vision North Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: August 25, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)