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Refractive Surgery
LASIK vs SMILE Eye Surgery for Vision Correction
N/A
Waitlist Available
Led By Majid Moshirfar, MD
Research Sponsored by Hoopes Vision
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 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares the effects of two different eye surgeries on post-op vision.
Who is the study for?
This trial is for people aged 22-50 with near-sightedness or astigmatism, having a stable prescription that hasn't changed much in the last year. They should not have had previous eye surgeries, significant dry eyes, keratoconus, or certain other eye conditions. Pregnant women and those with uncontrolled diabetes or autoimmune diseases are excluded.
What is being tested?
The study compares visual outcomes of two types of laser eye surgery: Topography Guided LASIK on one eye and Small Incision Lenticule Extraction on the other. Each participant receives both procedures, one per eye, to see which provides better vision postoperatively.
What are the potential side effects?
Potential side effects include discomfort or pain after surgery, temporary visual disturbances like glare and halos around lights at night, dry eyes requiring drops for relief, and very rarely more serious complications affecting vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Corrected Visual Acuity
Uncorrected Visual Acuity
Secondary study objectives
Predictability of Intended Outcome
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Topography-Guided LASIKActive Control1 Intervention
Subjects receive Topography-Guided LASIK surgery on one eye.
Group II: Small Incision Lenticule ExtractionActive Control1 Intervention
Subjects receive Small Incision Lenticule Extraction surgery on one eye.
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Who is running the clinical trial?
Hoopes VisionLead Sponsor
Alcon ResearchIndustry Sponsor
730 Previous Clinical Trials
128,809 Total Patients Enrolled
Majid Moshirfar, MDPrincipal InvestigatorHoopes Vision
3 Previous Clinical Trials
212 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor plan to become pregnant during the study.I am between 22 and 50 years old.I do not have uncontrolled diabetes, unstable blood pressure, or unstable autoimmune conditions.I have a history of corneal dystrophies.My eyesight prescription has been stable for the last year.I have an eye condition affecting the shape of my cornea.I have had surgery to correct my vision.I have had or currently have herpetic keratitis.I can come back for all needed check-ups after surgery.I have been diagnosed with severe dry eye by a doctor.I am willing and able to follow medication instructions after surgery.My nearsightedness or nearsightedness with astigmatism is between -2.00 and -9.00 D.My eye surgery aims for perfect vision in both eyes without using monovision.I've stopped wearing hard or gas permeable lenses for 4 weeks and soft lenses for 5 days before my screening.I have or am suspected to have glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Topography-Guided LASIK
- Group 2: Small Incision Lenticule Extraction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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