Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Recruiting

• Conditions: Pseudophakia
• Interventions: Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve; Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire; Other: Quality of Vision After Surgery (QUVID) Questionnaire; Other: Visual Disturbance Questionnaire; Diagnostic Test: Topography and Tomography

• Registration Number: NCT06064916
• Lead Sponsor: Berkeley Eye Center

Brief Summary

This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*).

Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

Detailed Description

This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled.

Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL

Study Timeline

• Study Start: 2023-07-25
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT***/CCWET*)
2. Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
7. Residual refractive astigmatism ≤0.50 diopters
8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion Criteria

1. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR in either eye.
11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vivity IOL Group	Defocus Curve	Patients with bilateral implantation of Vivity IOLs.
Vivity IOL Group	Visual Disturbance Questionnaire	Patients with bilateral implantation of Vivity IOLs.
Vivity IOL Group	Visual Acuity	Patients with bilateral implantation of Vivity IOLs.
Vivity IOL Group	Intraocular Lens Satisfaction (IOLSAT) Questionnaire	Patients with bilateral implantation of Vivity IOLs.
Vivity IOL Group	Topography and Tomography	Patients with bilateral implantation of Vivity IOLs.
Vivity IOL Group	Quality of Vision After Surgery (QUVID) Questionnaire	Patients with bilateral implantation of Vivity IOLs.

Primary Outcome Measures

Name	Time	Method
Binocular Best Corrected Distance Visual Acuity	3 weeks post operatively	Binocular Best Corrected Distance Visual Acuity

Secondary Outcome Measures

Name	Time	Method
Monocular vision	3 weeks post operatively	Monocular UCDVA (uncorrected distance visual acuity), UCIVA (uncorrected intermediate visual acuity), UCNVA (uncorrected near visual acuity), and BCDVA (best corrected distance visual acuity)
Binocular distance, intermediate, and near visual acuity	3 weeks post operatively	Binocular distance, intermediate, and near visual acuity
Self-reported visual disturbances	3 weeks post operatively	Self-reported visual disturbances
Intraocular Lens Satisfaction (IOLSAT) questionnaire	3 weeks post operatively	Patient self-reported satisfaction and quality of vision
Post-op refraction	3 weeks post operatively	Post-op refraction
Quality of Vision After Surgery (QUVID) questionnaire	3 weeks post operatively	Patient self-reported satisfaction and quality of vision

Trial Locations

Locations (1)

Berkeley Eye Center; 🇺🇸 Houston, Texas, United States