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Procedure

SMILE vs. LASIK for Near-Sightedness

N/A
Waitlist Available
Led By Charisma B Evangelista, MD
Research Sponsored by 59th Medical Wing
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month post-op
Awards & highlights

Study Summary

This trial studies a new eye surgery to correct nearsightedness in both eyes, using 2 different techniques.

Who is the study for?
This trial is for men and women aged 21-50 with nearsightedness between -2.00 and -8.00 diopters, astigmatism up to 3.00 diopters, similar vision issues in both eyes, Tricare Prime beneficiaries, living within 60 miles of Lackland AFB.Check my eligibility
What is being tested?
The study compares SMILE surgery on one eye versus LASIK using Contoura with Phorcides on the other eye to correct myopia (nearsightedness) and astigmatism.See study design
What are the potential side effects?
Potential side effects may include discomfort or pain in the eyes, visual disturbances like glare or halos, dry eyes, potential need for retreatment or glasses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
Secondary outcome measures
Change in high contrast visual acuity at 6-month Post-Op
Change in refractive error at 6-month Post-Op
Other outcome measures
Change in higher order aberrations at 6-month Post-Op
Change in low contrast visual acuity at 6-month Post-Op
Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op
+1 more

Trial Design

2Treatment groups
Active Control
Group I: LASIK using Contoura with PhorcidesActive Control1 Intervention
LASIK using Contoura with Phorcides in one eye.
Group II: SMILEActive Control1 Intervention
small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.

Find a Location

Who is running the clinical trial?

59th Medical WingLead Sponsor
39 Previous Clinical Trials
12,444 Total Patients Enrolled
Charisma B Evangelista, MDPrincipal Investigator59th Medical Wing
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

LASIK Using Contoura With Phorcides (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05844397 — N/A
Astigmatism Research Study Groups: LASIK using Contoura with Phorcides, SMILE
Astigmatism Clinical Trial 2023: LASIK Using Contoura With Phorcides Highlights & Side Effects. Trial Name: NCT05844397 — N/A
LASIK Using Contoura With Phorcides (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844397 — N/A

Frequently Asked Questions

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

Is there a minimum age requirement to participate in this trial?

"This clinical trial is recruiting participants aged 21 to 50 years old."

Answered by AI

Are my criteria compatible with the requirements of this research project?

"This clinical trial, which has a total of 56 participants, is seeking patients who have astigmatism and are between 21 to 50 years old."

Answered by AI

Are there any further participants needed for this research endeavor?

"Clinicaltrials.gov confirms that this medical study, initially posted on the 15th of May 2023 and modified on 3rd same month, is no longer actively recruiting patients. Nevertheless, there are 139 other clinical trials admiting candidates at present."

Answered by AI

Who else is applying?

What site did they apply to?
Wilford Hall Ambulatory Surgical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
SMILE vs. LASIK Using Contoura With Phorcides
2023. "SMILE vs. LASIK Using Contoura With Phorcides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844397.
All > Myopia
~0 spots leftby May 2024
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