Clinical trial NCT06064916: Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Official title: Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Keywords: Vivity
Pseudophakia
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with healthy eyes, prior myopic LASIK or PRK with SA greater than 0.3, and uncomplicated bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*).

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

Eligibility criteria: 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)

Primary outcomes:
measure: Binocular Best Corrected Distance Visual Acuity
timeFrame: 3 weeks post operatively
Secondary outcomes:
measure: Monocular Visual Acuity
timeFrame: 3 weeks post operatively
measure: Binocular Distance, Intermediate, and Near Visual Acuity
timeFrame: 3 weeks post operatively
measure: Quality of Vision After Surgery (QUVID) Questionnaire
timeFrame: 3 weeks post operatively
measure: Intraocular Lens Satisfaction (IOLSAT) Questionnaire
timeFrame: 3 weeks post operatively
measure: Post-op Refraction
timeFrame: 3 weeks post operatively
Other outcomes:
measure: Binocular Defocus Curve
timeFrame: 3 weeks post operatively
measure: Spectacle Independence (IOLSAT)
timeFrame: 3 weeks post operatively
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: