Visual Outcomes After Vivity Toric IOL Implantation

Refractive Assessment Clinical Trial

Official title:

Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04675489
• Other study ID #: 20-01
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: December 2020
• Source: EVP Eye Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.

Description:

To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
• Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
• Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator

Exclusion Criteria:

• Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
• Ocular trauma or zonular weakness/instability
• Diagnosis of glaucoma or high-risk glaucoma suspect
• Previous refractive surgery
• Unreliable preoperative biometry measurements
• Severe dry eye or ocular surface disease

Related Conditions & MeSH terms

• Refractive Assessment

Intervention

Other:
• Procedure: Vivity Toric IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.

Locations

Country	Name	City	State
United States	Icon Eye Care	Grand Junction	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
EVP Eye Care	Alcon Research, Icon Eye Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular visual acuity at distance	Monocular uncorrected distance visual acuity	4 months
Primary	Binocular visual acuity at distance	Binocular uncorrected distance visual acuity	4 months
Primary	Monocular best corrected distance visual acuity	Monocular best corrected distance visual acuity	4 months
Primary	Binocular best corrected distance visual acuity	Binocular best corrected distance visual acuity	4 months
Primary	Monocular best distance-corrected intermediate visual acuity	Monocular best distance-corrected intermediate visual acuity	4 months
Primary	Binocular best distance-corrected intermediate visual acuity	Binocular best distance-corrected intermediate visual acuity	4 months
Primary	Monocular best distance-corrected near visual acuity	Monocular best distance-corrected near visual acuity	4 months
Primary	Binocular best distance-corrected near visual acuity	Binocular best distance-corrected near visual acuity	4 months
Secondary	Residual refractive cylinder	Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.	4 months