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

Berkeley Eye Center

Status

Enrolling

Conditions

Pseudophakia

Treatments

Diagnostic Test: Defocus Curve

Diagnostic Test: Topography and Tomography

Other: Quality of Vision After Surgery (QUVID) Questionnaire

Other: Intraocular Lens Satisfaction (IOLSAT) Questionnaire

Diagnostic Test: Visual Acuity

Other: Visual Disturbance Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT06064916

69865263

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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*)
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
Able to comprehend and willing to sign informed consent and complete all required testing procedures
Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
Clear intraocular media
Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification)
Residual refractive astigmatism ≤0.50 diopters
Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion criteria

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
Any complication during cataract surgery (capsular tear, vitrectomy, etc)
History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions
Amblyopia or strabismus in either eye
History of or current anterior or posterior segment inflammation of any etiology
Any form of neovascularization on or within the eye
Glaucoma (uncontrolled or controlled with medication)
Optic nerve atrophy
Subjects with diagnosed degenerative eye disorders
Postoperative CDVA worse than 0.10 logMAR in either eye.
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)