← Back to Search

Procedure

Wavefront-guided LASIK for Presbyopia

N/A
Recruiting
Research Sponsored by AMO Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The refractive error of both subject's eyes, based on the iDesign refraction selected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or without astigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention
At least one eye must require a myopic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will enroll 383 people at 8-14 sites to study an experimental surgery. The follow-up visit schedule will be the same for each eye that has the surgery.

Who is the study for?
This trial is for people over 40 with myopia and presbyopia who need at least +1.25 D to +2.00 D reading add power, have stable vision, and can follow the study's schedule. Pregnant women or those on certain medications affecting healing are excluded.Check my eligibility
What is being tested?
The trial tests a LASIK surgery using iDesign Refractive Studio with STAR S4 IR® Excimer laser System for monovision correction in myopic subjects with presbyopia over a period of 12 months across multiple centers.See study design
What are the potential side effects?
Potential side effects may include discomfort, dry eyes, light sensitivity, visual disturbances like glare or halos around lights, and potential undercorrection or overcorrection of vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eyesight is nearsighted up to -6.00 D with astigmatism up to -3.00 D, and my non-dominant eye is as nearsighted as the treatment targets.
Select...
One of my eyes needs treatment for nearsightedness.
Select...
I am 40 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in driving scale score from preoperative to postoperative as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire
The proportion of subjects who required secondary surgery to reverse monovision

Trial Design

1Treatment groups
Experimental Treatment
Group I: Wavefront-guided Lasik Monovision TreatmentExperimental Treatment1 Intervention
Wavefront-guided LASIK monovision treatment of myopic subjects with presbyopia using the STAR S4 IR® Excimer laser System with the iDesign Refractive Studio.

Find a Location

Who is running the clinical trial?

AMO Development, LLCLead Sponsor
Johnson & Johnson Surgical Vision Inc. Clinical TrialStudy DirectorJohnson & Johnson Surgical Vision, Inc.
AMO Development, LLC Clinical TrialStudy DirectorAMO Development, LLC

Media Library

Wavefront-guided LASIK (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04075591 — N/A
Wavefront-guided LASIK (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are conducting this experiment?

"Presently, this clinical trial is hosted by 8 different hospitals that are located in cities like Sioux Falls, Houston and Ogden. To minimize any travel inconveniences for participants, it would be ideal to pick the closest medical facility."

Answered by AI

Is this research endeavor enrolling participants at the present time?

"Information available on clinicaltrials.gov reveals that this trial is currently searching for new recruits. It was initially posted back in September 24th 2019 and the information has been recently updated as of November 28th 2022."

Answered by AI

What is the participant quota for this clinical trial?

"Affirmative. Details published on clinicaltrials.gov reveal that this trial, initially advertised in September of 2019, is actively recruiting participants from 8 distinct sites and needs 383 patients to enroll."

Answered by AI

Who else is applying?

What site did they apply to?
Texas Eye & Laser Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am hoping this will help.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia
2019. "Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075591.
All > Vision
~116 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top