Patient Satisfaction and Visual Outcomes After Bilateral Implantation of a Novel Non-Diffractive Extended Vision Toric Intraocular Lens
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Refractive Assessment
- Sponsor
- EVP Eye Care
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Monocular best distance-corrected near visual acuity
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Monocular best distance-corrected near visual acuity
Time Frame: 4 months
Monocular best distance-corrected near visual acuity
Monocular best corrected distance visual acuity
Time Frame: 4 months
Monocular best corrected distance visual acuity
Monocular visual acuity at distance
Time Frame: 4 months
Monocular uncorrected distance visual acuity
Binocular visual acuity at distance
Time Frame: 4 months
Binocular uncorrected distance visual acuity
Binocular best corrected distance visual acuity
Time Frame: 4 months
Binocular best corrected distance visual acuity
Binocular best distance-corrected intermediate visual acuity
Time Frame: 4 months
Binocular best distance-corrected intermediate visual acuity
Binocular best distance-corrected near visual acuity
Time Frame: 4 months
Binocular best distance-corrected near visual acuity
Monocular best distance-corrected intermediate visual acuity
Time Frame: 4 months
Monocular best distance-corrected intermediate visual acuity
Secondary Outcomes
- Residual refractive cylinder(4 months)