NCT04075591

Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Post-approval Study of Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: AMO Development, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of refractive stability. After signing the informed consent, subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery. The follow-up visit schedule will be the same for each operative eye.

Conditions

• Refractive Error

Interventions

Type	Name	Description
DEVICE	iDesign Refractive Studio with STAR S4 IR® Excimer laser System	Surgeons will perform wavefront-guided monovision LASIK for the treatment of myopic subjects with presbyopia based upon measurements obtained with an iDesign Refractive Studio.

Timeline

• Start date: 2019-09-24
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2019-08-30
• Last updated: 2025-07-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study