Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients

Cataract Clinical Trial

Official title:

Visual Performance of the Vivity IOL in Post-myopic LASIK and PRK Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05961046
• Other study ID #: JH-23-01
• Status: Terminated
• Start date: August 17, 2023
• Est. completion date: June 13, 2024

Study information

• Verified date: June 2024
• Source: Laser & Corneal Surgery Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Vivity IOL
Vivity IOL

Locations

Country	Name	City	State
United States	LCSA Manhattan	New York	New York
United States	LCSA White Plains	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Laser & Corneal Surgery Associates	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular corrected distance visual acuity		3 months after surgery
Secondary	Monocular uncorrected visual acuity	At distance, intermediate, and near	3 months after surgery
Secondary	Monocular corrected visual acuity	At distance, intermediate, and near	3 months after surgery
Secondary	Binocular corrected visual acuity	At intermediate and near	3 months after surgery
Secondary	Binocular uncorrected visual acuity	At distance, intermediate, and near	3 months after surgery
Secondary	Binocular Defocus curve		3 months after surgery
Secondary	Satisfaction Questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months after surgery
Secondary	Visual Disturbance Questionnaire	Lower scores indicate less severe visual disturbances.	3 months after surgery
Secondary	Refractive Outcomes	Manifest refraction spherical equivalent (MRSE), residual sphere, astigmatism	3 months after surgery