Clinical trial NCT05961046: Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Official title: Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Lead sponsor: Laser & Corneal Surgery Associates
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-07-27
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months ago.

Brief summary: The objective is to evaluate visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL.

Detailed description: This study Prospective, non-interventional, single-center, single-surgeon, single-arm observational study of visual outcomes and patient satisfaction in patients with a history of myopic LASIK or PRK who will have completed cataract surgery with the Vivity IOL. Subjects will be assessed at least 3 months postoperatively. Clinical evaluations will include administration of a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities, defocus curve, and manifest refraction.

Eligibility criteria: Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Adult (at least 40 years) patients with a history of successful myopic LASIK/PRK and underwent bilateral uncomplicated cataract surgery with non-toric Alcon Vivity IOL at least 3 months before enrollment.
* Monocular BCDVA 20/25 or better.
* Patients may be \>2 weeks post-YAG capsulotomy for visually significant PCO.
* Post-operative sphere ≤0.50D, astigmatism ≤0.50D, and MRSE \< 0.75D.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patients with corneal refractive surgery complications, significant ocular pathology, including moderate and severe dry eye, retina, optic nerve (including glaucoma) and corneal pathologies (e.g. corneal dystrophy, edema, significant scarring), limiting or affecting visual potential, in the opinion of the surgeon.
* Patients undergoing cataract removal with MIGS procedure.
* Patients with h/o ocular surgery, other than corneal refractive surgery, that may limit or affect visual potential in the opinion of the surgeon.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Primary outcomes:
measure: Binocular corrected distance visual acuity
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Monocular uncorrected visual acuity
timeFrame: 3 months after surgery
measure: Monocular corrected visual acuity
timeFrame: 3 months after surgery
measure: Binocular corrected visual acuity
timeFrame: 3 months after surgery
measure: Binocular uncorrected visual acuity
timeFrame: 3 months after surgery
measure: Binocular Defocus curve
timeFrame: 3 months after surgery
measure: Satisfaction Questionnaire
timeFrame: 3 months after surgery
measure: Visual Disturbance Questionnaire
timeFrame: 3 months after surgery
measure: Refractive Outcomes
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: LCSA Manhattan
state: New York
city: White Plains
country: United States
facility: LCSA White Plains
state: New York
Study officials:
affiliation: Laser and Corneal Surgery Associates
name: Jimmy Y Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: