Visual Outcomes After Vivity Toric IOL Implantation

Not Applicable

Terminated

• Conditions: Refractive Assessment

• Registration Number: NCT04675489
• Lead Sponsor: EVP Eye Care

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-13
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Study Start: 2021-01-15
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Monocular best distance-corrected near visual acuity	4 months	Monocular best distance-corrected near visual acuity
Monocular best corrected distance visual acuity	4 months	Monocular best corrected distance visual acuity
Monocular visual acuity at distance	4 months	Monocular uncorrected distance visual acuity
Binocular visual acuity at distance	4 months	Binocular uncorrected distance visual acuity
Binocular best corrected distance visual acuity	4 months	Binocular best corrected distance visual acuity
Binocular best distance-corrected intermediate visual acuity	4 months	Binocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected near visual acuity	4 months	Binocular best distance-corrected near visual acuity
Monocular best distance-corrected intermediate visual acuity	4 months	Monocular best distance-corrected intermediate visual acuity

Secondary Outcome Measures

Name	Time	Method
Residual refractive cylinder	4 months	Manifest postoperative refractive cylinder (measured in diopters, with a phoropter) after cataract surgery and IOL implantation.

Trial Locations

Locations (1)

Icon Eye Care; 🇺🇸 Grand Junction, Colorado, United States