Long-term Outcomes of SMILE PRO for High Astigmatism (NCT07446751) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long-term Outcomes of SMILE PRO for High Astigmatism
Vietnam113 participantsStarted 2024-12-10
Plain-language summary
This prospective interventional study aims to evaluate the long-term refractive and visual quality outcomes of SMILE PRO surgery in patients with myopia and high astigmatism. Eligible participants undergo small incision lenticule extraction using the VisuMax 800 femtosecond laser. Postoperative assessments include uncorrected and corrected distance visual acuity, manifest refraction, astigmatic vector analysis, contrast sensitivity, and higher-order aberrations. Participants are followed for up to 12 months to assess refractive accuracy, stability, safety, and visual quality after surgery.
Who can participate
Age range
18 Years – 40 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 aged 18 to 40 years at the time of surgery
* Diagnosis of myopia with high astigmatism eligible for SMILE PRO surgery
* Stable refractive error prior to surgery
* Adequate corneal thickness and topographic parameters suitable for SMILE PRO
* Ability to understand the study procedures and provide written informed consent
* Willingness and ability to attend scheduled postoperative follow-up visits
Exclusion Criteria:
* Presence of corneal ectatic disorders or suspicious corneal topography
* History of previous ocular surgery or ocular trauma
* Active ocular disease other than refractive error
* Systemic diseases known to affect wound healing
* Pregnancy or breastfeeding at the time of surgery
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.