Study Summary
This trial will test the VisuMax femtosecond laser for small-incision lenticule extraction (SMILE) to correct myopia with or without astigmatism.
- Near-sightedness
- Astigmatism
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 10 Secondary · Reporting Duration: latter of 2 postoperative refractions performed at least 3 months apart or at 3 months after surgery when compared with the 1 month interval
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Low cylinder (no treatment)
1 of 2
Low cylinder (treatment)
1 of 2
Active Control
Experimental Treatment
180 Total Participants · 2 Treatment Groups
Primary Treatment: Visumax spherocylindrical treatment · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
What site did they apply to?
| Navy Warfighter Refractive Surgery Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
How many participants can join this trial?
"Affirmative. Clinicaltrials.gov's records demonstrate that this project, which was first posted on May 1st 2019, is still seeking participants. 180 patients are required to be recruited from one specific medical centre." - Anonymous Online Contributor
What is the end goal of this investigation?
"Over the course of 12 months, this trial intends to assess its participants’ distance visual acuity. Secondary objectives include determining best corrected visual acuity (through Method 1), calculating a monotonic decrease in mean rate of spherical equivalent refraction over time and noting any adverse events that may arise." - Anonymous Online Contributor
Are there any vacancies for participants in this research program?
"As per information hosted on clinicaltrials.gov, this investigation is actively searching for participants. The trial was initially announced in May of 2019 and the most recent update was posted April 14th 2022." - Anonymous Online Contributor