Characterization of the Corneal Biomechanics of Patients Treated by Corneal Lenticule Extraction … (NCT04817592) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Characterization of the Corneal Biomechanics of Patients Treated by Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) to Correct Myopia
Switzerland100 participantsStarted 2026-06-01
Plain-language summary
This study aims to perform biomechanical tests on extracted CLEAR lenticles that are routinely discarded after surgery. The investigators also aim to perform Brillouin microscopy to get an in-vivo assessment of the patient's cornea preoperatively and to correlate this data with the postoperative characterization of the extracted corneal lenticule. The characterization will be done with established biomechanical and morphologic tests.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled for CLEAR procedures for myopia (range: \>-3D with an astigmatism \<0.25D) in the age group 20-50 years.
* Willing and able to return for scheduled follow-up examinations
* Able to provide written informed consent and follow study instructions in English or German
Exclusion Criteria:
* Irregular corneal topo-/tomography (Asymmetry \>1.0D within the inner 5mm)
* Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes.
* History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative intraocular pressure (IOP) \> 21 mmHg in either eye.
* History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it might open for enrollment, and would it make sense to keep it on our radar while we explore other options in the meantime?
2I see this study is specifically looking at the biomechanics of the corneal tissue removed during lenticule extraction for myopia correction — can you explain what that means for me as a patient, and whether participating would change anything about how my procedure is actually performed?
3Since this trial is listed as 'Phase NA,' which suggests it's more of an observational or measurement study rather than a treatment trial, does that mean my treatment plan would stay the same, and the study is just analyzing tissue that's already being removed?
4How does lenticule extraction compare to other surgical options for correcting my level of myopia, and is my prescription within the range this study is targeting for 'advanced refractive correction'?
5Are there any risks or additional steps involved in participating in this study — for example, would my removed corneal tissue be sent somewhere for analysis, and are there privacy or consent considerations I should understand before agreeing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.