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

NCT04075591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2025-07-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • AMO Development, LLC

    lead INDUSTRY

Principal Investigators

  • AMO Development, LLC Clinical Trial · AMO Development, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2025-06-25
Completion
2025-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075591 on ClinicalTrials.gov