Actively Recruiting
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Led by Suphi Taneri · Updated on 2024-11-29
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the long-term effects of Small Incision Lenticule Extraction (SMILE) for correcting high myopia, specifically myopia greater than -7.75 diopters. This technique uses a femtosecond laser to create and remove a small corneal tissue disk called a lenticule, aiming to improve vision with minimal discomfort. The study seeks to gather data on visual and refractive stability, rare complications, and overall effectiveness in a large patient group. The study involves patients undergoing SMILE with the Visumax femtosecond laser system. This minimally invasive procedure creates a lenticule inside the cornea which is then extracted through a small incision. The trial focuses on eyes with high myopia to assess the outcomes and safety of this laser-based correction over time. Participants will be monitored for at least one year after the procedure. Researchers will measure subjective distance refraction and distance visual acuity to evaluate vision improvements. Additional assessments include corneal stability using Pentacam imaging and epithelial thickness via optical coherence tomography. The study aims to provide comprehensive data on the long-term results and safety of SMILE for high myopia correction.
CONDITIONS
Brief Title
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Myopia worse than -7.75 diopters
- Stable vision without significant changes for more than 1 year
You will not qualify if you...
- Corneal irregular astigmatism
- Ectatic (thinning or bulging) corneal conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo Small Incision Lenticule Extraction (SMILE) surgery to correct high myopia followed by immediate post-operative care.
1 surgery visit and immediate post-operative assessment
Duration - 1 year
Participants are monitored for visual acuity, stability, and corneal health after surgery.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Center for Refractive Surgery
Münster, North Rhine-Westphalia, Germany, 48145
Actively Recruiting
Research Team
S
Suphi Taneri, MD
A
Anika Förster, M.Sc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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