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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05488769
• Other study ID #: TN-22-001
• Status: Terminated
• Start date: August 25, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: January 2023
• Source: Vision North Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Visually significant age-related cataracts bilaterally.
• Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
• Gender: Males and Females.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Clear intraocular media other than cataract.
• Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
• IOL powers between 6D and 30D, T2-T6. If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
• 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.

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Canada	Vision North Eye Centre	Terrace	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Nagy	Sengi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative
Other	Visual disturbances questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Other	Binocular uncorrected and distance-corrected visual acuity at near (40cm)		3 months postoperative
Primary	Binocular distance-corrected visual acuity at distance (6m)		3 months postoperative
Primary	Binocular distance-corrected visual acuity at intermediate (66cm)		3 months postoperative
Secondary	Percentage of eyes with absolute prediction error less than or equal to 0.50D		3 months postoperative
Secondary	Percentage of eyes with refractive astigmatism less than or equal to 0.50 D		3 months postoperative